Catalog Number

8888301614

Brand Name

Argyle

Version/Model Number

8888301614

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

ede3e186-50d4-4377-a676-1bcdd6bc5ffd

Public Version Date

June 08, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

30884527019650

Quantity per Package

50

Contains DI Package

20884527019653

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE