Catalog Number

4-002536-00

Brand Name

Puritan Bennett

Version/Model Number

4-002536-00

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K890193,K890193

Product Code

BYG

Product Code Name

MASK, OXYGEN

Public Device Record Key

3ad6296b-a245-4a02-83da-9eb352a0fe5d

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

Package DI Number

10884521127104

Quantity per Package

999

Contains DI Package

20884521127101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack_or_inner_pack