| Primary Device ID | 00810008210345 |
| NIH Device Record Key | 5094b37f-aae0-4666-a9ab-b2697a2e9bb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-CARE PLUS Safety Lancets |
| Version Model Number | 1002 ONE-CARE PLUS Safety Lancets 28G x 1.8mm, Min |
| Catalog Number | 1002 |
| 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 | true |
| 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 | |
| Phone | 4045142586 |
| info@medivena.com |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 28 Gauge |
| Length | 1.8 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008210185 [Primary] |
| GS1 | 00810008210345 [Package] Contains: 00810008210185 Package: Case [20 Units] In Commercial Distribution |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-16 |
| 00810008210307 | Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.8 mm are designed with an ergonomic body |
| 00810008210314 | Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.4 mm are designed with an ergonomic body |
| 00810008210321 | Contact-activated ONE-CARE PLUS Safety Lancets 21G x 1.8 mm are designed with an ergonomic body |
| 00810008210338 | Contact-activated ONE-CARE PLUS Safety Lancets 25G x 1.8 mm are designed with an ergonomic body |
| 00810008210345 | Contact-activated ONE-CARE PLUS Safety Lancets 28G x 1.8 mm are designed with an ergonomic body |
| 00810008210352 | Contact-activated ONE-CARE PLUS Safety Lancets 30G x 1.5mm are designed with an ergonomic body f |