NA - CUSTOM PACK CB3E70R5 CRF PACK - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CUSTOM PACK CB3E70R5 CRF PACK

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

CB3E70R5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 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

K891687

Product Code Details

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

656499a6-b60c-4e51-b578-e406a900d2dc

Public Version Date

December 19, 2018

Public Version Number

4

DI Record Publish Date

June 11, 2015

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