Primary Device ID | 00860012134007 |
NIH Device Record Key | 9ac98349-1e82-4ba8-bf57-86f1816c5d12 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Blood Glucose Monitoring System LIVE TULA |
Version Model Number | TD-4266 |
Company DUNS | 062385494 |
Company Name | TULA HEALTH, INC. |
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 | false |
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 |
---|---|
GS1 | 00860012134007 [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 | 2024-06-24 |
Device Publish Date | 2024-06-15 |
00850065253275 - LIVE TULA LT-THIN Lancets(100PCS/BOX) | 2025-04-28 |
00850065253244 - LIVE TULA Alcohol Pads 1.0 (100pcs/box) | 2025-03-26 |
00850065253213 - LIVE TULA Blood Glucose Control Solution W2 | 2024-12-16 |
00860012134007 - Blood Glucose Monitoring System LIVE TULA | 2024-06-24 |
00860012134007 - Blood Glucose Monitoring System LIVE TULA | 2024-06-24 |
00860012134021 - Blood Glucose Test Strips (50pcs/box) LIVE TULA | 2024-06-24 |