Arctic Front Advance Pro™
GUDID 00763000431457
CATH AFAPRO23 AFA PRO 23 US PB
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 | 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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