Freezor®

GUDID 00643169504745

CATHETER 307F5 FREEZOR5 LONG ORANGE 7F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter
Primary Device ID00643169504745
NIH Device Record Key76557b59-1db7-4b17-96ff-55dc4c48f342
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreezor®
Version Model Number307F5
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169504745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-18

On-Brand Devices [Freezor®]

00643169023444CATHETER 307F1 FREEZOR1 SHT RED 7F
00643169023437CATHETER 307F3 FREEZOR3 MED BLUE 7F
00643169023420CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
00643169504769CATHETER 307F1 FREEZOR1 SHT RED 7F
00643169504752CATHETER 307F3 FREEZOR3 MED BLUE 7F
00643169504745CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
00643169450417CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
00643169450400CATHETER 307F3 FREEZOR3 MED BLUE 7F
00643169450394CATHETER 307F1 FREEZOR1 SHT RED 7F

Trademark Results [Freezor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREEZOR
FREEZOR
75664372 2498756 Live/Registered
MEDTRONIC CRYOCATH LP
1999-03-19

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