Duet® - BAG 46912 DRAINAGE DEHP-FREE 10PK - MEDTRONIC PS MEDICAL, INC.

Duns Number:089055867

Device Description: BAG 46912 DRAINAGE DEHP-FREE 10PK

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More Product Details

Catalog Number

-

Brand Name

Duet®

Version/Model Number

46912

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

DEN120017

Product Code Details

Product Code

GWM

Product Code Name

Device, monitoring, intracranial pressure

Device Record Status

Public Device Record Key

9e5d1fce-617a-427c-9b97-b9c6e52e98f1

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC PS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1465