Catalog Number

-

Brand Name

PORTEX

Version/Model Number

27-8000

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"

Yes

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

-

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

dc785578-4fbb-40ba-8907-f4686c51c6c1

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

March 12, 2021

Package DI Number

35019517123092

Quantity per Package

10

Contains DI Package

15019517123098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case