TERUFLEX TRANSFER BAG - TERUFLEX TRANSFER BAG - TERUMO CORPORATION

Duns Number:690543319

Device Description: TERUFLEX TRANSFER BAG

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More Product Details

Catalog Number

-

Brand Name

TERUFLEX TRANSFER BAG

Version/Model Number

BB*T015CB70

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"

-

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

KSR

Product Code Name

Container, Empty, For Collection & Processing Of Blood & Blood Components

Device Record Status

Public Device Record Key

6fc59f4e-1fe5-4a64-9389-86e83cdf6e52

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

54987350704134

Quantity per Package

4

Contains DI Package

34987350704130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29