| Primary Device ID | 00850071330120 |
| NIH Device Record Key | d6a89274-9260-4d3b-9f87-71210af6e96d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | prolaio Convenience Kit |
| Version Model Number | G |
| Company DUNS | 118827870 |
| Company Name | Prolaio, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850071330120 [Primary] |
| 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 |
| 00850071330120 | prolaio Convenience Kit - Model G |
| 00850071330113 | prolaio Convenience Kit - Model E |
| 00850071330106 | prolaio Convenience Kit - Model A |
| 00850071330090 | prolaio Convenience Kit - Model B |
| 00850071330083 | prolaio Convenience Kit - Model F |
| 00850071330076 | prolaio Convenience Kit - Model C |
| 00850071330069 | prolaio Convenience Kit - Model D |