Catalog Number

-

Brand Name

Blood - Urine Specimen Convenience Kit

Version/Model Number

SA93010

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

-

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

K101502,K101502

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

89b65459-8630-414d-9c63-045a515c6edf

Public Version Date

January 03, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2018

Package DI Number

30859952006025

Quantity per Package

48

Contains DI Package

10859952006021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case