| Primary Device ID | 00860013530204 |
| NIH Device Record Key | db8b279a-554a-4977-b1d0-53ac247dc7cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genteel BT100 |
| Version Model Number | BT-100M |
| Catalog Number | BT-100M |
| Company DUNS | 133895468 |
| Company Name | LIGHT HILL MEDICAL CORPORATION |
| 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 | 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 | false |
| OTC Over-The-Counter | true |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com | |
| Phone | 503.862.6498 |
| support@mygenteel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860013530204 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| 00860013530211 | Genteel Test Strips for the Genteel BT100-M Blood Glucose Meter. Pack of 50. |
| 00860013530204 | Genteel Blood Glucose Meter |