Medical Devices

Name:

CADD Solis

Indications: Intravenous, Intra-arterial, subcutaneous, intraperitoneal, peripheral nerve blocks, surgical site infusion, epidural space, subarachnoid space. The pump is intended for therapies that require: Continuous Rate of Infusion and/or an Intermittent Bolus and/or with Patient-Controlled Demand Doses and/or Clinician Boluses

Pump Size: 1.6 in. x 4 in. x 5 in. excluding cassette or other accessories. 1.6 in. x 4 in. x 7 in. with CM attached Screen 

Size: 2.12 in. x 2.12 in. (320 pixels x 320 pixels) 

Weight: 21 oz. (595g) including 4 AA alkaline batteries excluding other accessories. 

On-board Protocol Library: Stores up to 500 protocols 

Security Cassette/keypad lock and three customizablesecurity access levels: Keypad Code, Clinician Code, Administrator Code 

Accuracy:  +/- 6% (nominal) 

Delivery Methods: Continuous rate, PCA dose, Clinician bolus and Intermittent Bolus 

Reservoir Volume: 0 to 9999 mL programmable in 1 mL increments displayed in 0.1 mL increments 

Units: Milliliters (mL), Milligrams (mg), Micrograms (mcg)

Name:

Neutraclear™ + Cap

Category: NEUTRACLEARTM BIDIRECTIONAL NEEDLELESS INJECTION VALVES

Technical Features:
* Flow rate: 140 ml/min (under a water column of 100 cm)
* Backpressure resistance: 2.60 bar
* Maximum injection pressure: 325 PSI / 22 bar for a maximum injection flow rate of 10 ml/sec
* Valve with neutral displacement: very low fluid displacement while disconnecting the male luer connector – 0.004 ml      
* Priming volume: 0.049 ml
* Duration of use: 7 days lipido-resistant. Do not exceed 600 activations. 
* Total length: 2.8 cm

Manufacturer: CAIR LGL, France

DA Registration Number: MDR-09840

Name:

Spider 2 Ways Extension Line 10cm D:2.5mm + Neutraclear™ Macro

Category: PU/PVC 2-WAY EXTENSION TUBINGS WITH NEUTRACLEAR

Technical Features:
* Spider: 2 ways 
* Tubing Length: 10cm
* Total Length: ~ 18 cm
* Residual Length:~ 1.53 ml
* Maximum injection pressure: 325 PSI / 22 bar for a maximum injection flow rate of 10 ml/sec
* Back pressure resistance: 2.60 bar

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09843

Name:

Spider Double Lumen + Neutraclear™ + Clamps

Category: PU/PVC 2-WAY EXTENSION TUBINGS WITH NEUTRACLEARTM

Technical Features:   
* Spider: 2-ways
* Total Length: ~ 13.5 cm
* Residual Volume:~ 0.46 m
* Backpressure resistance: 2.60 bar 
* Maximum injection pressure: 325 PSI / 22 bar for a maximum injection flow rate of 10 ml/sec

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10367

Name:

Spider Triple Lumen + 2 Neutraclear™ 1mm Micro

Category: PU/PVC 3-WAY EXTENSION TUBINGS WITH NEUTRACLEAR

Technical Features:    
* Spider: 3-ways    
* Total Length: ~ 14 cm
* Residual Volume:~ 0.67 mL
* Backpressure resistance: 2.60 bar
* Maximum injection pressure: 325 PSI / 22 bar for a maximum injection flow rate of 10 ml/sec

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09841

Name:

Spider Triple Lumen + 3 Neutraclear™ + 3 Clamps 2.5mm

Category: PU/PVC 3-WAY EXTENSION TUBINGS WITH NEUTRACLEAR

Technical Features:   
* Spider: 3 ways 
* Tubing Length: 10cm
* Total Length: ~ 18 cm
* Residual Length:~ 2.35 ml
* Maximum injection pressure: 325 PSI / 22 bar for a maximum injection flow rate of 10 ml/sec
* Back pressure resistance: 2.60 bar

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09598

Name:

3 Way Stopcock with 1 Neutraclear™

Category: 3-WAY STOPCOCKS WITH WITH NEUTRACLEAR

Technical Features:     
* Neutraclear™ valve with neutral displacement: very low fluid displacement while disconnecting the male luer connector: - 0.004 ml.     
* Priming volume: 0.049 ml    
* Duration of use: 7 days lipido-resistant. Do not exceed 600 activations     
* Leakage resistance: 2 bar / 29 PSI (according to the NF EN ISO 8536-4/8/9/10 standards)     
* Backpressure resistance: 2 bar    
* Residual volume: ± 0.44 ml     
* Total length: ± 3.8 cm LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09423

Name:

3 Way Stopcock With Rotating Mobile Ring CAIR Swing + 2 Neutraclear™

Category: 3-WAY STOPCOCKS WITH WITH NEUTRACLEARTM

Technical Features:
* Maximal pressure of use: 2 bars per 15 seconds (continuous) and/or 5 bars (immediate)
* Lipido-resistant: 7 days
* Residual volume: 0.42 ml LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10119
 

Name:

Flowrate Controller Latex

Category: EXTENSION TUBING WITH DOSICAIR FLOW REGULATOR AND NEUTRACLEARTM

Technical Features:
* Component: Extension Tubing + Dosicair Flow Regulator + Y Inj Neutraclear + MLL + Mobile Ring       
* Residual volume: 2 ml     
* Diameter: 2.5 x 4.1 mm LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09599

Name:

Infusion Set with Dosicair and Neutraclear™

Category: INFUSION SETS WITH DOSICAIR FLOW REGULATOR AND NEUTRACLEAR

Technical Features:    
* Component: Infusion Line + Drip Chamber + Dosicair Flow Regulator + Y Inj Neutraclear
* Drip chamber in PVC (1 ml = 20 drops), filter in Nylon 15 μ, a spike in ABS with air-vent, protective cap in PE.
* Tube in PVC, Ø 2.5 x 4.1 mm, L = 125 cm
* “Dosicair” flow regulator: body in PC, joint in SI. Graduation from 5 to 250 ml/h
* Tube in PVC, Ø 2.5 x 4.1 mm, L = 65 cm
* Y derivation connector in ABS and Neutraclear® transparent bidirectional valve: seal in POM, key in SI, body in transparent PC, cannula in lipido-resistant transparent PC
* Tube in PVC, Ø 2.5 x 4.1 mm, L = 13.5 cm
* Luer lock male connector in ABS with a protective cap in PE

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09893

Name:

2 Stopcocks Manifold + 3 Neutraclear™ and 1 Male Port

Category: MALE STOPCOCKS MANIFOLDS WITH NEUTRACLEAR

Technical Features:
* Neutraclear™ valve with neutral displacement: very low fluid displacement while disconnecting the male luer connector: - 0.004 ml. 
* Backpressure resistance: 2.60 bars.
* Residual Volume = 0.73mL       
* Duration of use: 7 days lipido-resistant. Do not exceed 400 activations LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09426

Name:

3 Stopcocks Manifold + 4 Neutraclear™ and 1 Male Port

Category: MALE STOPCOCKS MANIFOLDS WITH NEUTRACLEAR

Technical Features:      
* Description:4 Neutraclear®+ 1 LLM outlet
* Residual Volume: 0.99 ml
* Neutraclear® valve with neutral displacement: very low fluid displacement while disconnecting the     
  male luer connector: - 0.004 ml. 
* Backpressure resistance: 2.60 bars.
* Duration of use: 7 days lipido-resistant. Do not exceed 400 activations LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10357

Name:

4 Stopcocks Manifold + 5 Neutraclear™ and 1 Male Port

Category: MALE STOPCOCKS MANIFOLDS WITH NEUTRACLEAR

Technical Features:
* Description:5 Neutraclear®+ 1 LLM outlet     
* Residual Volume: 1.40 ml    
* Neutraclear® valve with neutral displacement: very low fluid displacement while disconnecting the male luer connector: - 0.004 ml.
* Back pressure resistance: 2.60 bars.
* Duration of use: 7 days lipido-resistant. Do not exceed 400 activations LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10359

Name:

Infusion Set with Y Connection and Neutraclear™ (Macrodrip)

Category: INFUSION SET WITH NEUTRACLEAR

Technical Features:
      * Spike in ABS, drop-chamber in PVC (20 drops = 1 ml), filter in nylon, air-vent, and protective cap in PE
      * Tube in PVC, Ø 3 x 4.1 mm, L= 150 cm
      * Roller-clamp in ABS
      * White clamp in PP
      * Y connection in transparent ABS
      * Neutraclear® needless bidirectional injection valve: guide and sealing ring in POM, key in transparent      
         SI, body in transparent PC, cannula in lipid-resistant PC
      * Tube in PVC, Ø 3 x 4.1 mm, L= 30 cm
      * Male luer lock connector in ABS with mobile ring in PP and protective cap in PE LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09842

Name:

Infusion Set with Y Connection and Neutraclear™ (Microdrip)

Category: INFUSION SET WITH NEUTRACLEAR

Technical Features:
      * Spike in ABS, micro drip-chamber in PVC (60 drops = 1 ml), filter in nylon, air-vent and protective cap in PE
      * Tube in PVC, Ø 3 x 4.1 mm, L= 150 cm
      * Roller-clamp in ABS
      * White clamp in PP
      * Y connection in transparent ABS
      * Neutraclear® needleless bidirectional injection valve: guide and sealing ring in POM, key in transparent SI, body in         transparent PC, cannula in lipid-resistant PC
      * Tube in PVC, Ø 3 x 4.1 mm, L= 30 cm
      * Male luer lock connector in ABS with mobile ring in PP and protective cap in PE LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10358

Name:

Spike with Needle-Free Injection Site for Bag

Category: INFUSION SET WITH NEUTRACLEARTM

Technical Features:
      * Spike in ABS and protective cap in PE
      * Cair-Drive: body in PC, key in SI
      * Residual volume: 0.45 ml

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-10134

Name:

Vented Spike + CAIR Drive + Non- Return Valve

Category: INFUSION SET WITH NEUTRACLEAR

Technical Features:
      * Protective cap in PE
      * Spike in ABS with air-vent
      * Luer lock the female connector in PVC and tube in PVC, Ø 4.5 x 6.8 mm, L= 2 cm
      * Dead volume: ± 0.6 ml
      * Non-return valve (anti-injection): body in acrylic and valve in SI
      * Cair-Drive: body in PC, key in SI LATEX FREE, NON-DEHP

Manufacturer: CAIR LGL, France

FDA Registration Number: MDR-09844