Freezor® MAX
GUDID 00763000245474
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
Cardiac cryosurgical system catheter| Primary Device ID | 00763000245474 |
| NIH Device Record Key | b6719dca-4a6e-4872-a8aa-f47af1877204 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freezor® MAX |
| Version Model Number | 239F3 |
| 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 | |
| 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
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000245474 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100010
FDA Product Code
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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 | 2021-01-01 |
| Device Publish Date | 2020-12-24 |
On-Brand Devices [Freezor® MAX]
| 00613994804273 | CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F |
| 00643169023505 | CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F |
| 00643169023499 | CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F |
| 00643169023482 | CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F |
| 00643169023475 | CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F |
| 00643169504929 | CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F |
| 00643169504912 | CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F |
| 00643169504905 | CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F |
| 00643169504899 | CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F |
| 00643169450387 | CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F |
| 00643169450370 | CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F |
| 00643169450363 | CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F |
| 00643169450356 | CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F |
| 00763000245474 | CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F |
| 00763000245481 | CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F |
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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