TSCD®-II - Weld Integrity Test Kit for TSCD®II Sterile - TERUMO BCT, INC.

Duns Number:801679200

Device Description: Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder

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More Product Details

Catalog Number

-

Brand Name

TSCD®-II

Version/Model Number

62003

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

BK860041

Product Code Details

Product Code

KSB

Product Code Name

SET, TRANSFER (BLOOD/PLASMA)

Device Record Status

Public Device Record Key

bde22bce-0d8d-4425-84f9-066bf3c53c08

Public Version Date

August 09, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TERUMO BCT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 27