Catalog Number

8884726100

Brand Name

Argyle

Version/Model Number

8884726100

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)

Yes

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

a739b592-f39e-4138-a2a5-b2a5c4ae33c6

Public Version Date

February 15, 2019

Public Version Number

3

DI Record Publish Date

May 20, 2018

Package DI Number

10884521214125

Quantity per Package

6

Contains DI Package

20884521214122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE