| Primary Device ID | 00850071330038 |
| NIH Device Record Key | 6a4e1caa-bc17-4fc2-954b-15cc18ceee56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | prolaio Personalized Physiology Analytics Engine Software (PPA) |
| Version Model Number | 1.0 |
| Company DUNS | 118827870 |
| Company Name | Prolaio, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com | |
| Phone | 855-869-9054 |
| support@prolaio.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850071330038 [Primary] |
| PLB | Multivariate Vital Signs Index |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-23 |
| Device Publish Date | 2025-06-13 |
| 00850071330007 - prolaio Mobile App | 2025-06-23 prolaio medical device data system mobile application |
| 00850071330014 - prolaio Cloud | 2025-06-23 prolaio medical device data system cloud |
| 00850071330038 - prolaio Personalized Physiology Analytics Engine Software (PPA) | 2025-06-23prolaio Personalized Physiology Analytics Engine Software |
| 00850071330038 - prolaio Personalized Physiology Analytics Engine Software (PPA) | 2025-06-23 prolaio Personalized Physiology Analytics Engine Software |
| 00850071330045 - prolaio Heart Rhythm and Respiration Module | 2025-06-23 prolaio Heart Rhythm and Respiration Module |
| 00850071330069 - prolaio Convenience Kit | 2025-06-23 prolaio Convenience Kit - Model D |
| 00850071330076 - prolaio Convenience Kit | 2025-06-23 prolaio Convenience Kit - Model C |
| 00850071330083 - prolaio Convenience Kit | 2025-06-23 prolaio Convenience Kit - Model F |
| 00850071330090 - prolaio Convenience Kit | 2025-06-23 prolaio Convenience Kit - Model B |