| Primary Device ID | 50383017941258 |
| NIH Device Record Key | 10b95319-8eb9-4591-8d61-300bf0821187 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | embecta Insulin Syringe |
| Version Model Number | 329412 |
| Catalog Number | 329412 |
| Company DUNS | 118777356 |
| Company Name | Embecta Medical II, LLC |
| Device Count | 10 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Needle Gauge | 27 Gauge |
| Length | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10383017941212 [Primary] |
| GS1 | 30383017941230 [Package] Contains: 10383017941212 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 50383017941258 [Package] Contains: 30383017941230 Package: Case [5 Units] In Commercial Distribution |
| GS1 | 80383017941280 [Unit of Use] |
| FMF | Syringe, piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-22 |
| 50383017673050 | embecta™ Insulin Syringes, U-500, 6mm, 31G, 0.5mL |
| 30383017946532 | embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL |
| 50383017946154 | embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL |
| 50383017942453 | embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL, 2 units |
| 50383017942057 | embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL |
| 50383017941258 | embecta™ Insulin Syringes, U-100, 16mm, 27G, 1mL |
| 30383017941032 | embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL |