| Primary Device ID | 20858835007800 |
| NIH Device Record Key | e32fd3a9-34a6-4e0e-a067-753656270c89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1cc Insulin Syringe w/ Bio-Guard Safety Needle |
| Version Model Number | BIO-IN-1001 |
| Catalog Number | BIO-IN-1001 |
| Company DUNS | 065762392 |
| Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858835007806 [Primary] |
| GS1 | 10858835007803 [Package] Contains: 00858835007806 Package: Inner Box [100 Units] In Commercial Distribution |
| GS1 | 20858835007800 [Package] Contains: 10858835007803 Package: Case [12 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-10-10 |
| 10850005165573 - Biotroix Healthcare Syringes | 2024-03-19 Syringe 1cc Luer Lock without needle, Each |
| 10850005165290 - Biotronix Healthcare Suture Removal Tray | 2021-02-08 Suture Removal Tray |
| 10850005165009 - Biotronix Healthcare Foley Trays | 2019-12-24 Pre-Connected Latex Foley Tray 18FR |
| 10850005165016 - Biotronix Healthcare Urethral Catheter Trays | 2019-12-24 Intermittent Urethral Catheter Tray 14FR, PVC |
| 10850005165023 - Biotronix Healthcare Enema Bag Set | 2019-12-24 Enema Bag Set |
| 10850005165030 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Bulb Syringe |
| 10850005165047 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Piston Syringe |
| 10850005165054 - Biotronix Healthcare | 2019-12-24 Minor Laceration Tray w/ Instrument |