NA - CUSTOM PACK BB11V67R3 UMC - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CUSTOM PACK BB11V67R3 UMC

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

BB11V67R3

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

K171979

Product Code Details

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Device Record Status

Public Device Record Key

099c98f0-30bc-45d6-ba7e-6208cc8605b0

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

May 01, 2022

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