| Primary Device ID | 00810008210604 |
| NIH Device Record Key | 668c10d2-7415-4341-b1bd-2c4ce2e969ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-CARE Safety Pen Needles 30G x 5mm, Pink, |
| Version Model Number | 3101-ONE-CARE Safety Pen Needles 30G x 5mm, Pink, |
| Catalog Number | 3101 |
| 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 | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 5 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008210000 [Primary] |
| GS1 | 00810008210604 [Package] Contains: 00810008210000 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 00810008210635 [Package] Package: case [24 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 | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 00810008211434 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008215449 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008218860 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008216538 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008216569 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008216620 - ONE-CARE Luer-Lock Syringes | 2025-06-26 The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration o |
| 00810008211540 - ONE-CARE Pen Needles, | 2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp |
| 00810008211656 - ONE-CARE Pen Needles | 2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp |