AUTOTRANSFUSION RESERVOIR

GUDID 38033178105386

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system container
Primary Device ID38033178105386
NIH Device Record Key01c5bd70-b883-4a32-adaa-066538cbd280
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOTRANSFUSION RESERVOIR
Version Model NumberBT844 + CYA
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
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
GS108033178105385 [Primary]
GS138033178105386 [Package]
Contains: 08033178105385
Package: BOX [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-08
Device Publish Date2015-07-15

On-Brand Devices [AUTOTRANSFUSION RESERVOIR]

38033178105393BT844 + EXTENSION LINE
38033178105386BT844 + CYA
38033178105379BT894 + CYA

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