TERUMO SAMPLING SITE COUPLER - TERUMO SAMPLING SITE COUPLER - TERUMO CORPORATION

Duns Number:690543319

Device Description: TERUMO SAMPLING SITE COUPLER

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More Product Details

Catalog Number

-

Brand Name

TERUMO SAMPLING SITE COUPLER

Version/Model Number

TC*MP1

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

KSS

Product Code Name

Supplies, Blood-Bank

Device Record Status

Public Device Record Key

0a980d1f-3f42-4ed4-ab1e-2b1fe7ee33b0

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

54987350731277

Quantity per Package

20

Contains DI Package

34987350731273

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