Catalog Number

SA94633

Brand Name

Blood-Urine Specimen Kit

Version/Model Number

SA94633

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

901e20f1-711a-48e0-8d93-4763a29d2464

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 21, 2017

Package DI Number

10859952006168

Quantity per Package

48

Contains DI Package

00859952006161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton