Catalog Number

29-7997-050

Brand Name

Astraguard

Version/Model Number

KK Flotube

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 26, 2019

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

ba5c3188-91aa-413d-b07d-0c3c1b64e48d

Public Version Date

March 23, 2020

Public Version Number

5

DI Record Publish Date

July 26, 2016

Package DI Number

B279S297997200

Quantity per Package

50

Contains DI Package

B279S297997050

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

case