DAC Cardiotomy

GUDID 08033178102292

SORIN GROUP ITALIA SRL

Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp
Primary Device ID08033178102292
NIH Device Record Key3819078d-f8b8-4f4e-8104-4ca03ef48ed5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAC Cardiotomy
Version Model NumberD714 Holder
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033178102292 [Primary]

FDA Product Code

KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-01
Device Publish Date2023-10-24

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38033178018709 - Suction tip2024-04-12
38033178018716 - Suction tip2024-04-12
38033178018723 - Suction tip2024-04-12
38033178018730 - Suction tip2024-04-12

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