Catalog Number

L770-040

Brand Name

Life Support Products

Version/Model Number

L770-040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K973106,K973106

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

0b027856-8bc2-42c6-a891-7b6f4061635c

Public Version Date

May 05, 2020

Public Version Number

5

DI Record Publish Date

December 10, 2015

Package DI Number

20026072001411

Quantity per Package

6

Contains DI Package

00026072001417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case