| Primary Device ID | 04719871820100 |
| NIH Device Record Key | 7234effc-daf0-4b34-a3df-a9774c001b87 |
| Commercial Distribution Discontinuation | 2016-05-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Easy Plus II |
| Version Model Number | 8818(BZ8818G0HAB) |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719871820100 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 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 | 2016-05-02 |
| 04719871820124 | Easy Plus II Control Solution Kit-Low |
| 04719871820117 | Easy Plus II Control Solution Kit-High |
| 04719871820100 | Easy Plus II Test Strip 25x2 |
| 04719871820094 | Easy Plus II Control Solution-Low |
| 04719871820087 | Easy Plus II Control Solution-High |
| 04719871820070 | Easy Plus II Blood Glucose Test Strip |
| 04719871820063 | Easy Plus II Glucose Meter, 6276-S |
| 04719871820056 | Easy Plus II Blood Glucose Monitoring System 6276-S |