Catalog Number

8884714200

Brand Name

Argyle

Version/Model Number

8884714200

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

a4384d58-9b02-4ecb-9963-f39b14b8fc12

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521104089

Quantity per Package

24

Contains DI Package

10884521104082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE