| Primary Device ID | 00761059841845 |
| NIH Device Record Key | a8f438dd-deb6-4bce-84fa-1e9b42809a32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 32G |
| Version Model Number | AN 3840DO |
| Company DUNS | 803401454 |
| Company Name | OWEN MUMFORD USA INCORPORATED |
| 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 | 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 | true |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 32 Gauge |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384703840003 [Unit of Use] |
| GS1 | 00761059840848 [Primary] |
| GS1 | 00761059841845 [Package] Contains: 00761059840848 Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00761059842842 [Package] Package: Case [5 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-04 |
| Device Publish Date | 2021-05-27 |
| 00761059354024 - Unifine Pentips | 2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G |
| 00761059352921 - Unifine Pentips | 2024-01-30 Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G |
| 00384707001035 - Unistik VacuFlip | 2023-10-16 Unistik VacFlip, 20G Safety Needle 1" |
| 00384707102039 - Unistik VacuFlip | 2023-10-16 Unistik VacuFlip, 21G safety needle 1" with holder |
| 00384707117033 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing |
| 00384707122037 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing |
| 00384707312032 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing |
| 00384707317037 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing |