| Primary Device ID | 10852788008047 |
| NIH Device Record Key | 30552a40-fd6f-48a6-8e09-e2facb249c85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CloudCover Plus |
| Version Model Number | NL-SK-8S |
| Catalog Number | NL-SK-8S |
| Company DUNS | 074301687 |
| Company Name | NEOLIGHT LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10852788008047 [Primary] |
| GS1 | 20852788008105 [Package] Package: Bag [5 Units] In Commercial Distribution |
| LBI | Unit, Neonatal Phototherapy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2020-11-11 |
| 00852788008101 - NeoLight Bassinet Basket Loaner | 2025-04-17 The NeoLight Bassinet Basket Loaner is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker |
| 00852788008019 - Neolight | 2025-02-03 ICON Cart Control Box |
| 00852788008026 - Neolight | 2025-02-03 FA Module |
| 00852788008040 - Neolight | 2025-02-03 Diffuser |
| 00852788008057 - Neolight | 2025-02-03 ICON GO Control Box |
| 00852788008064 - Neolight | 2025-02-03 ICON Footswitch |
| 00852788008071 - Neolight | 2025-02-03 White Light Module |
| 10852788008085 - Neolight | 2025-02-03 ICON Handpiece |