Catalog Number

902-642

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

1e10caf6-5f47-420d-a843-454479d3a626

Public Version Date

December 18, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

H6719026421

Quantity per Package

25

Contains DI Package

H6719026420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box