Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ONE-CARE DUO Safety Pen Needles FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 3350 FDA UDI
- Primary DI / UDI-DI
- 00810008212080 FDA UDI
- 510(k) Number
- K210864 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDILength — 5 Millimeter FDA UDI
Category: Autoinjector needle
One-Care by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Autoinjector needle.
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- droplet®, pen needles — HTL STREFA S A · Class II
- Nano 2nd Gen — embecta Medical II LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
- Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
Cleared under the same submission
K210864 also covers:
- microdot® — Cambridge Sensors USA, LLC.
- EasyDrip ReadyGard Duo Safety Pen Needles 30G 6mm — Sandstone Medical (Suzhou) Inc.
- EasyDrip ReadyGard Duo Safety Pen Needles 31G 5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 30G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 30G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 30G×8mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 31G×8mm — Sandstone Medical (Suzhou) Inc.
- easydrip ReadyGard Duo Safety Pen Needles — Sandstone Medical (Suzhou) Inc.
- easydrip Readygard Duo Safety Pen Needles — Sandstone Medical (Suzhou) Inc.
- easydrip Readygard Duo Safety Pen Needles — Sandstone Medical (Suzhou) Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MediVena, LLC
Sources (1)
- FDA UDI 889c027c-0c8c-414d-b376-43e381515676 37 fields · synced May 30, 2026