Catalog Number

-

Brand Name

NA

Version/Model Number

S1001-6120

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

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

0248ccd0-40af-4725-aaeb-32b2a0e970b7

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Package DI Number

04719873695515

Quantity per Package

5

Contains DI Package

04719873695508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-