Portex - SMITHS MEDICAL ASD, INC.

Duns Number:828611934

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

21-7530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Yes

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 Details

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Device Record Status

Public Device Record Key

56284472-5081-4029-8701-7dfcbb8462d9

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITHS MEDICAL ASD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 36112