Freezor™ MAX

GUDID 00763000655143

CATHETER 209F5 FREEZOR MAX5 LG ORANGE9F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter
Primary Device ID00763000655143
NIH Device Record Key30cece2d-cae2-4556-86ae-dbe35194e8ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreezor™ MAX
Version Model Number209F5
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

Device Dimensions

Catheter Working Length90 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge9 French
Device Size Text, specify0
Catheter Working Length90 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge9 French
Device Size Text, specify0
Catheter Working Length90 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge9 French
Device Size Text, specify0
Catheter Working Length90 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge9 French
Device Size Text, specify0
Catheter Working Length90 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Catheter Gauge9 French
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000655143 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-10

On-Brand Devices [Freezor™ MAX]

00763000655143CATHETER 209F5 FREEZOR MAX5 LG ORANGE9F
00763000655136CATHETER 209F3 FREEZOR MAX3 MED BLUE 9F

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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