Catalog Number

PN-7212

Brand Name

Rejuvesol™

Version/Model Number

PN-7212

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

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

BK950060,BK950060

Product Code

KSB

Product Code Name

Set, Transfer (Blood/Plasma)

Public Device Record Key

7bed92ca-10df-4d71-b389-83f2e95ca8a8

Public Version Date

August 23, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-