Catalog Number

180008

Brand Name

PFT Kit, Disposable, AstraGuard / Noseclip

Version/Model Number

PFT Kit, Disposable, AstraGuard and Noseclip - 180008

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

K000654,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

23e1702a-4a16-447a-a72f-9686de869fa6

Public Version Date

March 05, 2020

Public Version Number

1

DI Record Publish Date

February 26, 2020

Package DI Number

00817081025439

Quantity per Package

50

Contains DI Package

00817081025422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-