Strapette - Pediatric Strapette™ with Small Tube Tackels - WESTMED, INC.

Duns Number:092673953

Device Description: Pediatric Strapette™ with Small Tube Tackels

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More Product Details

Catalog Number

-

Brand Name

Strapette

Version/Model Number

CP-4220

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

JAY

Product Code Name

Support, Breathing Tube

Device Record Status

Public Device Record Key

3ac48a57-fc90-486f-b933-7ee93167ed88

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Additional Identifiers

Package DI Number

10709078013062

Quantity per Package

40

Contains DI Package

00709078013065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320