Catalog Number

-

Brand Name

Level 1

Version/Model Number

D-100

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

BK860023,BK860023

Product Code

KZL

Product Code Name

DEVICE, WARMING. BLOOD AND PLASMA

Public Device Record Key

47033ba9-ebe8-44f7-8b86-58381946517c

Public Version Date

February 24, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

10695085410003

Quantity per Package

10

Contains DI Package

40695085410004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case