Catalog Number

-

Brand Name

PIVO 22G

Version/Model Number

202-0006

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

K163508,K163508

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

10e3e75d-21db-4334-8fac-0a0b4958548a

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

July 11, 2017

Package DI Number

10850984007031

Quantity per Package

50

Contains DI Package

00850984007034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Carton