ZOOM Aspiration Pump - ZOOM POD Aspiration Tubing, AFT117B - TAIWAN BIOMATERIAL COMPANY LIMITED

Duns Number:656073408

Device Description: ZOOM POD Aspiration Tubing, AFT117B

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More Product Details

Catalog Number

-

Brand Name

ZOOM Aspiration Pump

Version/Model Number

AFT117B

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

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Device Record Status

Public Device Record Key

cc13e0fa-8da6-4da4-8271-9a922e7191dc

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TAIWAN BIOMATERIAL COMPANY LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7