BRAT Accessory - LIVANOVA USA, INC.

Duns Number:080914995

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

BRAT Accessory

Version/Model Number

BRAT Accessory

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

K991986,K991986

Product Code Details

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Device Record Status

Public Device Record Key

cf9de64b-9a89-4f03-9880-064e6681c30b

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

June 13, 2016

Additional Identifiers

Package DI Number

10803622132305

Quantity per Package

10

Contains DI Package

00803622132308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"LIVANOVA USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 479
3 A medical device with high risk that requires premarket approval 30