NA - CUSTOM PACK 10G97R 10PK 3/8LINE65DUR - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CUSTOM PACK 10G97R 10PK 3/8LINE65DUR

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

10G97R

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

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

K800178,K800178

Product Code Details

Product Code

DWE

Product Code Name

TUBING, PUMP, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

93902e58-0f8d-4603-b379-e839bd8cb629

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2017

Additional Identifiers

Package DI Number

20763000076553

Quantity per Package

10

Contains DI Package

00763000076542

Package Discontinue Date

-

Package Status

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