| Primary Device ID | 20817522013333 |
| NIH Device Record Key | 22eaf4a3-52df-4ded-89c4-be88f3e5c418 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kentec electrode |
| Version Model Number | AMG-503-PED |
| Catalog Number | AMG-503-PED |
| Company DUNS | 066175613 |
| Company Name | KENTEC MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817522013336 [Primary] |
| GS1 | 20817522013333 [Package] Contains: 10817522013336 Package: box [50 Units] In Commercial Distribution |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-03 |
| Device Publish Date | 2024-04-25 |
| 20817522013371 - Swabeze | 2024-07-08 foam swab |
| 20817522013357 - Swabeze | 2024-07-05 foam swab |
| 20817522013364 - Swabeze | 2024-07-05 foam swab |
| 20817522013388 - Swabeze | 2024-07-05 foam swab |
| 20817522013340 - Swabeze | 2024-06-28 low absorption foam swab |
| 20817522010356 - Ameritus | 2024-06-06 large size ecg electrode |
| 20817522010363 - Ameritus | 2024-06-06 small size ecg electrode |
| 20817522013333 - Kentec electrode | 2024-05-035-lead electrode |
| 20817522013333 - Kentec electrode | 2024-05-03 5-lead electrode |