NA - RESERVOIR EL404 4L 40MICR CARDIOTOMY 6CA - MEDTRONIC, INC.

Duns Number:006261481

Device Description: RESERVOIR EL404 4L 40MICR CARDIOTOMY 6CA

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

EL404

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K926250,K926250

Product Code Details

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

c7fde8d1-5d5f-4a4e-a5f3-a838f4c79124

Public Version Date

September 22, 2022

Public Version Number

5

DI Record Publish Date

June 16, 2016

Additional Identifiers

Package DI Number

20673978523594

Quantity per Package

6

Contains DI Package

00673978523590

Package Discontinue Date

October 21, 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