| Primary Device ID | B510PT3000 |
| NIH Device Record Key | 1d07bd4c-55cc-4461-b35d-5fec8fdb0e52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVANCED PHOTOTHERAPY LAMP |
| Version Model Number | PT-3000 |
| Company DUNS | 608736880 |
| Company Name | ADVANCED INSTRUMENTATIONS, 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B510PT3000 [Primary] |
| PDH | Blanket, Neonatal Phototherapy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-29 |
| Device Publish Date | 2025-08-21 |
| B510PT3000 - ADVANCED PHOTOTHERAPY LAMP | 2025-08-29 |
| B510PT3000 - ADVANCED PHOTOTHERAPY LAMP | 2025-08-29 |
| B510PM200MPRO1 - ADVANCED PATIENT MONITOR | 2025-07-31 |
| B510V1000 - ADVANCED VENTILATOR | 2025-02-18 |
| B510A31860 - ADVANCED NEONATAL INCUBATOR | 2025-02-17 |
| B510A31861 - ADVANCED NEONATAL INCUBATOR | 2025-02-17 |
| B510A4051 - ADVANCED INFANT WARMER | 2025-02-17 |
| B510AM60001 - ADVANCED GAS-MACHINE ANESTHESIA | 2025-02-17 |
| B510FM9000 - ADVANCED FETAL MONITOR | 2025-02-17 |