APEX HP

GUDID 38033178109926

SORIN GROUP ITALIA SRL

Extracorporeal membrane oxygenator
Primary Device ID38033178109926
NIH Device Record Key04b00850-5590-4d76-a67b-b64b2efa648f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX HP
Version Model NumberAPEX HP PHISIO/SMARxT
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
GS108033178109925 [Primary]
GS138033178109926 [Package]
Contains: 08033178109925
Package: BOX [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2015-07-15

On-Brand Devices [APEX HP]

38033178109926APEX HP PHISIO/SMARxT
38033178109919APEX HP
38033178109902APEX HP M PHISIO

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