BRAT Accessory

GUDID 10803622132220

LIVANOVA USA, INC.

Blood-processing autotransfusion system set
Primary Device ID10803622132220
NIH Device Record Key21407efc-0006-4346-b1c1-1c9118d16bbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAT Accessory
Version Model NumberBRAT Accessory
Company DUNS080914995
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622132223 [Primary]
GS110803622132220 [Package]
Contains: 00803622132223
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-15
Device Publish Date2016-06-13

On-Brand Devices [BRAT Accessory]

10803622133067BRAT Accessory
10803622132312BRAT Accessory
10803622132305BRAT Accessory
10803622132299BRAT Accessory
10803622132282BRAT Accessory
10803622132275BRAT Accessory
10803622132268BRAT Accessory
10803622132251BRAT Accessory
10803622132244BRAT Accessory
10803622132237BRAT Accessory
10803622132220BRAT Accessory
10803622132213BRAT Accessory
10803622132206BRAT Accessory

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