Custom Perfusion System - CUSTOM PACK CB4H94R CRF PK - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CUSTOM PACK CB4H94R CRF PK

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More Product Details

Catalog Number

-

Brand Name

Custom Perfusion System

Version/Model Number

CB4H94R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2018

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

Yes

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

-

FDA Premarket Submission

K973011

Product Code Details

Product Code

KFM

Product Code Name

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Record Status

Public Device Record Key

acfb340e-9ddb-4cb4-b549-0e78faf4e81a

Public Version Date

December 11, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601