TRILLIUM® Affinity NT® - OXYGENATOR 95215 TRILLIUM AFF 511T 4PK - MEDTRONIC, INC.

Duns Number:006261481

Device Description: OXYGENATOR 95215 TRILLIUM AFF 511T 4PK

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More Product Details

Catalog Number

-

Brand Name

TRILLIUM® Affinity NT®

Version/Model Number

95215

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 14, 2019

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

K973760,K973760

Product Code Details

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

9627b7bd-47ee-4ce5-a8a9-e758bcbc1243

Public Version Date

October 19, 2022

Public Version Number

6

DI Record Publish Date

June 16, 2015

Additional Identifiers

Package DI Number

20613994865971

Quantity per Package

4

Contains DI Package

00613994865977

Package Discontinue Date

November 14, 2019

Package Status

Not in Commercial Distribution

Package Type

PK

"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