Catalog Number

-

Brand Name

BVF

Version/Model Number

2820

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K942779,K942779,K942779

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

59ca397b-5dec-4bf4-8ab7-6a1a57a3901c

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

November 28, 2016

Package DI Number

05099169283688

Quantity per Package

50

Contains DI Package

15099169283685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-