AMG PMP INFANT STERILE US5088

GUDID 18052705493365

EUROSETS SRL

Extracorporeal membrane oxygenator
Primary Device ID18052705493365
NIH Device Record Key4701dfa7-2202-40c4-85b8-93542e518521
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMG PMP INFANT STERILE
Version Model NumberAMG PMP INFANT STERILE
Catalog NumberUS5088
Company DUNS439962374
Company NameEUROSETS 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052705493368 [Primary]
GS118052705493365 [Package]
Contains: 08052705493368
Package: [1 Units]
In Commercial Distribution
GS128052705493362 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-27
Device Publish Date2025-02-19

Devices Manufactured by EUROSETS SRL

08034013785489 - HOLDER2025-02-27
18052705493358 - A.M.G.PMP PEDIATRIC 2025-02-27
18052705493365 - AMG PMP INFANT STERILE 2025-02-27
18052705493365 - AMG PMP INFANT STERILE 2025-02-27
18052705496250 - A.M.G. PP Sterile2020-05-19
08034013782037 - A.M.G. PMP Sterile2020-01-22

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