Freezor® MAX

GUDID 00643169504905

CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter
Primary Device ID00643169504905
NIH Device Record Key0d8566d8-9d19-44f9-86c4-bbc76aa20969
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreezor® MAX
Version Model Number239F3
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

Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169504905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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® MAX]

00613994804273CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169023505CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00643169023499CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169023482CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169023475CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169504929CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00643169504912CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169504905CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169504899CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169450387CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169450370CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169450363CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169450356CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00763000245474CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00763000245481CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F

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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