AUTOTRANSFUSION ACCESSORIES

GUDID 18033178105689

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system set
Primary Device ID18033178105689
NIH Device Record Keyeed6ce22-9192-4da8-9008-65cfab581df8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOTRANSFUSION ACCESSORIES
Version Model NumberCOD.150
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
GS108033178105682 [Primary]
GS118033178105689 [Package]
Contains: 08033178105682
Package: BOX [8 Units]
In Commercial Distribution
GS138033178105683 [Package]
Package: BOX [40 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 Date2021-01-08
Device Publish Date2015-07-15

On-Brand Devices [AUTOTRANSFUSION ACCESSORIES]

38033178110151VENTED WASTE BAG 10 LITERS
38033178105720BRB-1
18033178105689COD.150
18033178105610COD. 151 E
38033178105591BT845
38033178105560BT277 (BRB1)
38033178105461COD.150
38033178105447BT696
38033178105430BT697
38033178105478COD. 131E

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