Primary Device ID | 10852788008092 |
NIH Device Record Key | eb6276ec-4d1f-43a0-a22a-7662475e1745 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cloud Swaddle |
Version Model Number | NL-SK-5 |
Company DUNS | 074301687 |
Company Name | NEOLIGHT LLC |
Device Count | 5 |
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 | true |
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 | 10852788008092 [Primary] |
GS1 | 10852788008139 [Unit of Use] |
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 | 2020-01-06 |
Device Publish Date | 2018-11-09 |
10852788008047 - CloudCover Plus | 2024-02-16 CloudCover Plus (disposable) |
10852788008177 - CloudCover | 2024-02-16 CloudCover for use with Skylife Phototherapy System |
10852788008009 - Skylife Lightbed | 2020-01-06 Phototherapy Device |
10852788008016 - Skylife Controller | 2020-01-06 Device Controller (with system) |
10852788008023 - GelMat | 2020-01-06 GelMat |
30852788008058 - Light Module | 2020-01-06 Light Modules (2) installed in system |
10852788008078 - Skylife System | 2020-01-06 Phototherapy System |
10852788008092 - Cloud Swaddle | 2020-01-06Cloud Swaddles (disposable 5 pcs with system - labeled bag) |
10852788008092 - Cloud Swaddle | 2020-01-06 Cloud Swaddles (disposable 5 pcs with system - labeled bag) |