| Primary Device ID | 20858835007435 |
| NIH Device Record Key | 37d7dccf-392c-44bc-806f-84f9bf178b1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Syringe LL, W/BioCare Safety Needle |
| Version Model Number | BIO-1067S |
| Catalog Number | BIO-1067S |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00858835007431 [Primary] |
| GS1 | 10858835007438 [Package] Contains: 00858835007431 Package: Inner Box [50 Units] In Commercial Distribution |
| GS1 | 20858835007435 [Package] Contains: 10858835007438 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 | 2019-10-09 |
| 00858835007127 | Disposable 3cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2", Each |
| 20858835007749 | Disposable 5cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2" |
| 20858835007435 | Disposable 10cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2" |
| 20858835007176 | Disposable 5cc Syringe LL, W/BioCare Safety Needle 22G x 1 1/2", Each |
| 20858835007152 | Disposable 3cc Syringe LL, W/BioCare Safety Needle 23G x 1" |
| 20858835007145 | Disposable 3cc Syringe LL, W/BioCare Safety Needle 22G x 1 1/2" |
| 20858835007138 | Disposable 3cc Syringe LL, W/BioCare Safety Needle 22G x 1" |
| 20858835007107 | Disposable 3cc Syringe LL, W/BioCare Safety Needle 21G x 1" |