A.M.G. PP Sterile US5400

GUDID 18052705496250

EUROSETS SRL

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator
Primary Device ID18052705496250
NIH Device Record Key9d8f96c2-4e18-4b9c-85a7-f628c45c2aae
Commercial Distribution StatusIn Commercial Distribution
Brand NameA.M.G. PP Sterile
Version Model NumberA.M.G. MODULE PP NO T.TP.STER.
Catalog NumberUS5400
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39 0535660311
Emailkvesoviniregulatory@eurosets.com
Phone+39 0535660311
Emailkvesoviniregulatory@eurosets.com
Phone+39 0535660311
Emailkvesoviniregulatory@eurosets.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108052705496253 [Primary]
GS108052705496253 [Primary]
GS108052705496253 [Primary]
GS118052705496250 [Package]
Contains: 08052705496253
Package: [4 Units]
In Commercial Distribution
GS118052705496250 [Package]
Contains: 08052705496253
Package: [4 Units]
In Commercial Distribution
GS118052705496250 [Package]
Contains: 08052705496253
Package: [4 Units]
In Commercial Distribution
GS128052705496257 [Package]
Package: [1 Units]
In Commercial Distribution
GS128052705496257 [Package]
Package: [1 Units]
In Commercial Distribution
GS128052705496257 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass
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 Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by EUROSETS SRL

18052705496250 - A.M.G. PP Sterile2020-05-19
18052705496250 - A.M.G. PP Sterile2020-05-19
08034013782037 - A.M.G. PMP Sterile2020-01-22

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