Catalog Number

-

Brand Name

Level 1

Version/Model Number

PF-1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK860023,BK860023,BK860023

Product Code

KZL

Product Code Name

DEVICE, WARMING. BLOOD AND PLASMA

Public Device Record Key

1e0826a4-2c6a-4843-9230-df7e99c98220

Public Version Date

October 03, 2019

Public Version Number

1

DI Record Publish Date

September 25, 2019

Package DI Number

30695085400107

Quantity per Package

4

Contains DI Package

10695085400103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet