Freezor™
GUDID 00763000645335
CATHETER 207F3 FREEZOR3 MED BLUE 7F
MEDTRONIC, INC.
Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter| Primary Device ID | 00763000645335 |
| NIH Device Record Key | e396c414-745c-4d0c-8117-5fd027d8273f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freezor™ |
| Version Model Number | 207F3 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000645335 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P020045
FDA Product Code
| LPB | Cardiac ablation percutaneous catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-09 |
| Device Publish Date | 2022-04-30 |
On-Brand Devices [Freezor™]
| 00763000645342 | CATHETER 207F5 FREEZOR5 LONG ORANGE 7F |
| 00763000645335 | CATHETER 207F3 FREEZOR3 MED BLUE 7F |
| 00763000645328 | CATHETER 207F1 FREEZOR1 SHT RED 7F |
Trademark Results [Freezor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREEZOR 75664372 2498756 Live/Registered |
MEDTRONIC CRYOCATH LP 1999-03-19 |
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