Map-iT 901571
GUDID 00818083010621
Fixed, 10 electrode, CS, 2-5-2mm electrode spacing
ACCESS POINT TECHNOLOGIES, INC.
Catheter-tip electrode| Primary Device ID | 00818083010621 |
| NIH Device Record Key | e1d569b7-f83a-481f-b50b-e1f5490e7253 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Map-iT |
| Version Model Number | 901571 |
| Catalog Number | 901571 |
| Company DUNS | 128599565 |
| Company Name | ACCESS POINT TECHNOLOGIES, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Catheter Gauge | 4 French |
| Length | 65 Centimeter |
| Catheter Gauge | 4 French |
| Length | 65 Centimeter |
| Catheter Gauge | 4 French |
| Length | 65 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818083010621 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160390
FDA Product Code
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording |
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 | 2018-11-22 |
| Device Publish Date | 2018-10-22 |
On-Brand Devices [Map-iT]
| 00818087020541 | Fixed,6 electrode, MPB, 5-5-5-175-175mm electrode spacing |
| 00818087020534 | Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing |
| 00818087020527 | Fixed, 6 electrode, MPB, 5-5-5-175-175mm electrode spacing |
| 00818087020510 | Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing |
| 00818087020503 | STR, 4 electrode, MPD-CS-S, 5mm electrode spacing |
| 00818087020442 | Fixed, 4 electrode, MPB, 2mm electrode spacing |
| 00818087020435 | Fixed, 4 electrode, MPA, 2-5-2mm electrode spacing |
| 00818087020428 | Fixed, 4 electrode, MPB, 5mm electrode spacing |
| 00818087020404 | STR, 10 electrode, MPD-DL, 5mm electrode spacing |
| 00818087020398 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020381 | Fixed Curve Decapolar Catheter with Guidewire Tip |
| 00818087020374 | Shrouded Quad Extension Cable, Steerable 4 pole, Black, Reusable |
| 00818087020367 | Shrouded Quad Extension Cable, Red, Reusable |
| 00818087020350 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-D |
| 00818087020343 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-B |
| 00818087020336 | Steerable Quadripolar Catheter, Multi-Purpose D Curve-B |
| 00818087020329 | Shrouded Quad Extension Cable, Black, Reusable |
| 00818087020312 | Fixed Curve Quadripolar Catheter, Multi-Purpose A Curve |
| 00818087020305 | Shrouded Deca Extension Cable, Fixed 20 pole, Black, Reusable |
| 00818087020299 | Shrouded Deca Extension Cable, Steerable 10 pole, Black, Reusable |
| 00818087020282 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H |
| 00818087020275 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H |
| 00818087020268 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL |
| 00818087020251 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL |
| 00818087020244 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL |
| 00818087020237 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL |
| 00818087020220 | Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL |
| 00818087020213 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020206 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020190 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020183 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020176 | Fixed Curve Duo-Decapolar Catheter with Guidewire Tip |
| 00818087020169 | Fixed Curve Decapolar Catheter with Guidewire Tip |
| 00818087020152 | Fixed Curve Decapolar Catheter with Guidewire Tip |
| 00818087020145 | Fixed Curve Decapolar Catheter with Guidewire Tip |
| 00818087020138 | Fixed Curve Decapolar Catheter with Guidewire Tip |
| 00818087020121 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve |
| 00818087020114 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve |
| 00818087020107 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL |
| 00818087020091 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL |
| 00818087020084 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL |
| 00818087020077 | Steerable Decapolar Catheter, Multi-Purpose D Curve-SL |
| 00818087020060 | Steerable Decapolar PV Catheter, Pulmonary Vein 24 |
| 00818087020053 | Steerable Decapolar PV Catheter, Pulmonary Vein 21 |
| 00818087020046 | Steerable Decapolar PV Catheter, Pulmonary Vein 18 |
| 00818087020039 | Steerable Decapolar PV Catheter, Pulmonary Vein 15 |
| 00818087020022 | Steerable Decapolar PV Catheter, Pulmonary Vein 12 |
| 00818087020015 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve |
| 00818087020008 | Fixed Curve Decapolar Catheter, Multi-Purpose A Curve |
| 00818083019907 | Fixed, 10 electrode, S, 2-10-2mm electrode spacing |
Trademark Results [Map-iT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAP-IT 86674282 4895153 Live/Registered |
SOUTH-TEK SYSTEMS, LLC 2015-06-25 |
 MAP-IT 85921200 4685362 Live/Registered |
Access Point Technologies 2013-05-02 |
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