Catalog Number

-

Brand Name

NA

Version/Model Number

Frame F5-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K131414

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Public Device Record Key

9178013c-f4d4-4e75-aa5a-256f6f8bbbc9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-