Freezor™

GUDID 00763000645328

CATHETER 207F1 FREEZOR1 SHT RED 7F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter
Primary Device ID00763000645328
NIH Device Record Key6f2a3e5d-0221-4706-aee6-99a1e02649f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreezor™
Version Model Number207F1
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
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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0
Catheter Working Length108 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000645328 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-30

On-Brand Devices [Freezor™]

00763000645342CATHETER 207F5 FREEZOR5 LONG ORANGE 7F
00763000645335CATHETER 207F3 FREEZOR3 MED BLUE 7F
00763000645328CATHETER 207F1 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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