Catalog Number

116301

Brand Name

Bag, Breathing, 3-Liter Latex Free

Version/Model Number

Bag, Breathing, 3-Liter Latex Free - 116301

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

BTC

Product Code Name

Bag, Reservoir

Public Device Record Key

e225a49e-1154-4c22-9a25-61eb49df3578

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Package DI Number

00817081023220

Quantity per Package

10

Contains DI Package

00817081023213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-