ECMOtherm- II™

GUDID 30613994008702

Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable

Primary Device ID	30613994008702
NIH Device Record Key	d92646ba-f092-4b29-8a28-245f6279fec0
Commercial Distribution Status	In Commercial Distribution
Brand Name	ECMOtherm- II™
Version Model Number	61399400870
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
GS1	30613994008702 [Primary]
GS1	50613994008706 [Package] Package: PK [12 Units] In Commercial Distribution

DTR	HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Steralize Prior To Use	false
Device Is Sterile	true

00613994008701	EXCHANGER 61399400870 12CA EMOTRMII HT
30613994008702	EXCHANGER 61399400870 1EA EMOTHRMII HT