AirLIfe - Pediatric Manual Resuscitator; 40" (1.0m) Oxygen - Carefusion Corporation

Duns Number:830432451

Device Description: Pediatric Manual Resuscitator; 40" (1.0m) Oxygen Resevoir Tubing, Pediatric Mask, Pressure Pediatric Manual Resuscitator; 40" (1.0m) Oxygen Resevoir Tubing, Pediatric Mask, Pressure Limiting Valve with Lock, C02 Detector, Pressure Manometer

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More Product Details

Catalog Number

2K8008C2M

Brand Name

AirLIfe

Version/Model Number

2K8008C2M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OEV

Product Code Name

Cardiopulmonary Resuscitation Aid Kit

Device Record Status

Public Device Record Key

62142882-891c-42b7-91d1-e20dadb338c4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

50885403189812

Quantity per Package

6

Contains DI Package

10885403189814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"CAREFUSION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 876
3 A medical device with high risk that requires premarket approval 29