Arctic Front Advance Pro™
GUDID 00763000431457
CATH AFAPRO23 AFA PRO 23 US PB
MEDTRONIC, INC.
Cardiac cryosurgical system catheter| Primary Device ID | 00763000431457 |
| NIH Device Record Key | 101ffc86-3499-42ac-9a26-e818c5aa5475 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arctic Front Advance Pro™ |
| Version Model Number | AFAPRO23 |
| 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 Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
| Catheter Gauge | 10.5 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 95 Centimeter |
Operating and Storage Conditions
| 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 113 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 113 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 113 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 113 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 113 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 113 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 113 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 113 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 113 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 113 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 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000431457 [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 | 2021-11-15 |
| Device Publish Date | 2021-11-05 |
On-Brand Devices [Arctic Front Advance Pro™]
| 00643169889903 | CATH AFAPRO28 AFA PRO 28 US |
| 00643169889880 | CATH AFAPRO23 AFA PRO 23 US |
| 00763000197766 | CATH AFAPRO23 AFA PRO 23 US PB |
| 00763000088637 | CATH AFAPRO28 AFA PRO 28MM US PB |
| 00763000245436 | CATH AFAPRO28 AFA PRO 28 US |
| 00763000245412 | CATH AFAPRO23 AFA PRO 23 US |
| 00763000341503 | CATH AFAPRO28 AFA PRO 28 US MVC |
| 00763000341497 | CATH AFAPRO23 AFA PRO 23 US MVC |
| 00763000431464 | CATH AFAPRO28 AFA PRO 28 US |
| 00763000431457 | CATH AFAPRO23 AFA PRO 23 US PB |
| 00763000707781 | CATH AFAPRO28 AFA PRO 28 US MVC |
| 00763000707774 | CATH AFAPRO23 AFA PRO 23 US MVC |
Trademark Results [Arctic Front Advance Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCTIC FRONT ADVANCE PRO 87144212 5728288 Live/Registered |
Medtronic Cryocath LP 2016-08-19 |
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