Catalog Number

29-7991-050

Brand Name

Astraguard

Version/Model Number

klip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062913,K062913,K062913

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

76dee4ee-7de0-4438-8cdf-d83afa99c372

Public Version Date

March 23, 2020

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

B279S297991200

Quantity per Package

50

Contains DI Package

B279S297991050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case