ECMOtherm- II™

GUDID 00613994008701

EXCHANGER 61399400870 12CA EMOTRMII HT

MEDTRONIC, INC.

Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID00613994008701
NIH Device Record Key0ebe1d54-62eb-4e5e-a911-d1071575fdcc
Commercial Distribution Discontinuation2015-06-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameECMOtherm- II™
Version Model Number61399400870
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994008701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-06-09

On-Brand Devices [ECMOtherm- II™]

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

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