Catalog Number

000-0010

Brand Name

PIVO 20G

Version/Model Number

000-0010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2018

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

K142946,K152924,K142946,K152924

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

c93c90c7-739d-49e6-9403-18979baed04c

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

January 03, 2017

Package DI Number

10850984007000

Quantity per Package

50

Contains DI Package

00850984007003

Package Discontinue Date

July 01, 2018

Package Status

Not in Commercial Distribution

Package Type

Inner Pack