Freezor™
GUDID 00763000645328
CATHETER 207F1 FREEZOR1 SHT RED 7F
MEDTRONIC, INC.
Cardiac cryosurgical system catheter| Primary Device ID | 00763000645328 |
| NIH Device Record Key | 6f2a3e5d-0221-4706-aee6-99a1e02649f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freezor™ |
| Version Model Number | 207F1 |
| 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
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Working Length | 108 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000645328 [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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