Primary Device ID | 04719871820278 |
NIH Device Record Key | 0ecc8c69-a9ec-48d2-bf84-fe0e08c27287 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Oracle |
Version Model Number | GOD21/BLM001ROA |
Company DUNS | 658447255 |
Company Name | BIOTEST 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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-841-1109 |
Ben.Coffey@nurserosie.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04719871820278 [Primary] |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-11-29 |
04719871820292 | Oracle Control Solution - Low(BYGOD11BT) |
04719871820278 | Oracle Control Solution - Medium(BYGOD21BT) |
04719871820254 | Oracle Control Solution- High(BYGOD31BT) |
04719871820230 | Oracle Blood Glucose Test Strip(BY8818G0NL4) |
04719871820216 | Oracle Blood Glucose Monitoring System |