Catalog Number

8884724504

Brand Name

Argyle

Version/Model Number

8884724504

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

571a5511-c37e-4d34-a0eb-764d2e6f2263

Public Version Date

November 19, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

10884527000081

Quantity per Package

50

Contains DI Package

20884527000088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE