Catalog Number

902-632

Brand Name

N/A

Version/Model Number

Custom

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

CBT

Product Code Name

Arterial Blood Sampling Kit

Public Device Record Key

68c0e740-7e69-46b8-b30b-5ce7df554f5f

Public Version Date

December 18, 2019

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

H6719026321

Quantity per Package

50

Contains DI Package

H6719026320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box