SYNTHESIS M PH

GUDID 38033178109254

Extracorporeal membrane oxygenator

Primary Device ID	38033178109254
NIH Device Record Key	fb8e45b5-5b3d-45ec-81cd-6885cff76286
Commercial Distribution Status	In Commercial Distribution
Brand Name	SYNTHESIS M PH
Version Model Number	SYNTHESIS
Company DUNS	442126587
Company Name	SORIN GROUP ITALIA SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08033178109253 [Primary]
GS1	38033178109254 [Package] Contains: 08033178109253 Package: BOX [2 Units] In Commercial Distribution

DTZ	OXYGENATOR, CARDIOPULMONARY BYPASS

Steralize Prior To Use	false
Device Is Sterile	true