| Primary Device ID | 00810008211175 |
| NIH Device Record Key | 9981dcc6-4e13-4979-977c-81bdea6bb35d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-CARE Pen Needles |
| Version Model Number | 3012-ONE-CARE Pen Needles, 32G x 4mm, Green, 100ct |
| Catalog Number | 3012 |
| Company DUNS | 080740980 |
| Company Name | MediVena, LLC |
| 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 | 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 | true |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com | |
| Phone | 4045142586 |
| info@medivena.com |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008211168 [Primary] |
| GS1 | 00810008211175 [Package] Contains: 00810008211168 Package: case [50 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 | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00810008211632 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008215531 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008211175 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008211656 | he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |