| Primary Device ID | 00858935006358 |
| NIH Device Record Key | 980bffd4-b2c3-47be-891c-062b6e000e5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumen MD |
| Version Model Number | LM-NP2-S |
| Catalog Number | 602008 |
| Company DUNS | 080183509 |
| Company Name | HEALTHLIGHT 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 | false |
| Lot Batch | false |
| 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 | true |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com | |
| Phone | 224-231-0342 |
| cjohl@healthlightllc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858935006358 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2018-03-15 |
| 00858935006372 | Lumen MD Foot and Hand Pad System |
| 00858935006358 | Lumen MD Dual Foot and Ankle System |
| 00858935006341 | Lumen MD Foot and Ankle Pad System |