| Primary Device ID | 20858835007756 |
| NIH Device Record Key | 1ece95cf-5592-4f97-81d1-e8d9adb84a48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioCare Safety Needles |
| Version Model Number | BIO-1018S |
| 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 | 00858835007752 [Primary] |
| GS1 | 10858835007759 [Package] Contains: 00858835007752 Package: Inner Box [100 Units] In Commercial Distribution |
| GS1 | 20858835007756 [Package] Contains: 10858835007759 Package: Case [8 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 |
| 20858835007770 | Disposable BioCare Safety Needles 23G x 1 1/2" |
| 20858835007763 | Disposable BioCare Safety Needles 21G x 1 1/2" |
| 20858835007756 | Disposable BioCare Safety Needles 20G x 1 1/2" |
| 20858835007114 | Disposable BioCare Safety Needles 23G x 1" |
| 20858835007091 | Disposable BioCare Safety Needles 30G x 1/2" |
| 20858835007084 | Disposable BioCare Safety Needles 22G x 1 1/2" |
| 30858835007074 | Disposable BioGuard Safety Needles 18G x 1 1/2", |