AirLife™ - Manual Resuscitator II - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: Manual Resuscitator II

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More Product Details

Catalog Number

2K7012

Brand Name

AirLife™

Version/Model Number

2K7012

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

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Device Record Status

Public Device Record Key

689e4fce-fd40-42d6-ac71-c8772dc0defc

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Additional Identifiers

Package DI Number

50190752141382

Quantity per Package

6

Contains DI Package

10190752141384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"VYAIRE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 780
3 A medical device with high risk that requires premarket approval 65
U Unclassified 1