MVR™

GUDID 20643169767571

RESERVOIR MVR1600 VRB 1600ML 6PK

MEDTRONIC, INC.

Cardiotomy reservoir Cardiotomy reservoir
Primary Device ID20643169767571
NIH Device Record Key2a0ee24b-c2c5-4fda-95ac-2bcaffc9a742
Commercial Distribution StatusIn Commercial Distribution
Brand NameMVR™
Version Model NumberMVR1600
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 Perscriptionfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169767560 [Primary]
GS120643169767571 [Package]
Contains: 00643169767560
Package: PK [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2016-12-31

On-Brand Devices [MVR™]

20643169767595RESERVOIR MVR800 VRB 800ML 6PK
20643169767571RESERVOIR MVR1600 VRB 1600ML 6PK
20643169767557RESERVOIR CBMVR1600 BIOACT STERILE 6PK
20643169767533RESERVOIR CBMVR800 BIOACT STERILE 6PK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.