ONE-CARE 3350
GUDID 00810008212080
ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover and lock the needle to minimize the risk of accidental needle sticks.
MediVena, LLC
Autoinjector needle| Primary Device ID | 00810008212080 |
| NIH Device Record Key | 889c027c-0c8c-414d-b376-43e381515676 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-CARE |
| Version Model Number | ONE-CARE DUO Safety Pen Needles |
| Catalog Number | 3350 |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008212080 [Primary] |
| GS1 | 00810008214299 [Package] Package: Case [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210864
FDA Product Code
| FMI | Needle, Hypodermic, Single Lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-06 |
| Device Publish Date | 2023-09-28 |
On-Brand Devices [ONE-CARE]
| 00810008210994 | ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucos |
| 00810008210512 | ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative meas |
| 00810008210451 | ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fr |
| 00810008210499 | ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitat |
| 00810008210031 | ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose i |
| 00810008212103 | ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically |
| 00810008211939 | ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded a |
| 00810008212080 | ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutan |
Trademark Results [ONE-CARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONE-CARE 88267775 not registered Live/Pending |
MediVena, LLC 2019-01-18 |
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