| Primary Device ID | B7442259313 |
| NIH Device Record Key | 5b531578-152a-48c8-b15d-19cba8a6aac2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraFlo Insulin Syringe |
| Version Model Number | 225931 |
| Company DUNS | 054180248 |
| Company Name | QUALITY MEDICAL PRODUCTS USA, INC. |
| Device Count | 100 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B7442259310 [Unit of Use] |
| HIBCC | B7442259311 [Primary] |
| HIBCC | B7442259312 [Package] Contains: B7442259311 Package: Inner Case [5 Units] In Commercial Distribution |
| HIBCC | B7442259313 [Package] Contains: B7442259312 Package: Carton [6 Units] In Commercial Distribution |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2019-06-24 |
| B7442259453 | 0.3ML 31GX5/16" 1/2 UNIT MARKING |
| B7442259443 | 1 ML 31GX5/16" |
| B7442259433 | 1 ML 30GX5/16" |
| B7442259423 | 1 ML 30GX1/2" |
| B7442259413 | 1 ML 29GX1/2" |
| B7442259403 | 0.5 ML 31GX5/16" |
| B7442259393 | 0.5 ML 30GX5/16" |
| B7442259383 | 0.5 ML 30GX1/2" |
| B7442259373 | 0.5 ML 29GX1/2" |
| B7442259363 | 0.3 ML 31GX5/16" |
| B7442259353 | 0.3 ML 30GX5/16" 1/2 UNIT MARKING |
| B7442259343 | 0.3 ML 30GX5/16" |
| B7442259333 | 0.3 ML 30GX1/2" 1/2 UNIT MARKING |
| B7442259323 | 0.3 ML 30GX1/2" |
| B7442259313 | 0.3 ML 29GX1/2" |