Transfer Set - Bracco Injeneering SA

Duns Number:482489007

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More Product Details

Catalog Number

017349

Brand Name

Transfer Set

Version/Model Number

017349

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133147,K133147,K133147

Product Code Details

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Device Record Status

Public Device Record Key

c12e8f24-66e5-4f40-95d9-57ab2e399f7d

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

37630039300358

Quantity per Package

100

Contains DI Package

27630039300351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BRACCO INJENEERING SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84