Catalog Number

8888163030

Brand Name

Argyle

Version/Model Number

8888163030

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

K811409,K811409

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

038c64a9-c0d2-42c7-a081-26c48dc9da70

Public Version Date

March 22, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884527007100

Quantity per Package

10

Contains DI Package

10884527007103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE