| Primary Device ID | 00810000520466 |
| NIH Device Record Key | 21d235dc-4d2c-413d-96b7-2131d96a7dad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentle Pulse™ |
| Version Model Number | D631ADAPT |
| Catalog Number | D631ADAPT |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| 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 |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000520466 [Primary] |
| EAT | Tester, Pulp |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-17 |
| Device Publish Date | 2018-11-16 |
| M595D6360 | Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe |
| 00810000520473 | Ground Clip and Lead Wire for Gentle Pulse™ & Digitest™ Pulptesters |
| 00810000520466 | Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New |
| 00810000520459 | Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long) |
| 00810000520442 | Gentle Pulse™ Pulp Vitality Tester |
| 00810000520435 | Gentle Pulse™ Pulp Vitality Tester |
| M595D624MS0 | Gentle Pulse™ Pulp Vitality Tester |
| 00810000520978 | Gentle Pulse™ Pulp Vitality Tester (Korea) |
| 00810000520961 | Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)(Korea) |
| 00810000520077 | Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe |