Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically shielded and never exposed to prevent risk of accidental needle-sticks. Transparent shield allows clear visibility of the needle tip for easy priming. Needle Lock-Out is confirmed via disappearance of pink element after use to evidence that the needle has been permanently locked and can be safely disposed. Needle cannulas are of Ultra-Thin Wall technology, 30G diameter, tri-bevel, electropolished and lubricated. Universal design ensures tight fit and compatibility with different pens. FDA UDI
- Model / Reference
- ONE-CARE OPTI Safety Pen Needles 30G x 8mm FDA UDI
- Description
- ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically shielded and never exposed to prevent risk of accidental needle-sticks. Transparent shield allows clear visibility of the needle tip for easy priming. Needle Lock-Out is confirmed via disappearance of pink element after use to evidence that the needle has been permanently locked and can be safely disposed. Needle cannulas are of Ultra-Thin Wall technology, 30G diameter, tri-bevel, electropolished and lubricated. Universal design ensures tight fit and compatibility with different pens. FDA UDI
Identifiers
- Catalog Number
- 3302 FDA UDI
- Primary DI / UDI-DI
- 00810008212097 FDA UDI
- 510(k) Number
- K192677 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDILength — 8 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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Cleared under the same submission
K192677 also covers:
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- Pen Needle — GERI-GENTLE CORPORATION
- True Comfort Safety Pen Needles 4MM 32G — HOME AIDE DIAGNOSTICS, INC.
- True Comfort Safety Pen Needles 5MM 31G — HOME AIDE DIAGNOSTICS, INC.
- True Comfort Safety Pen Needles 6MM 31G — HOME AIDE DIAGNOSTICS, INC.
- True-Comfort Safety Pen Needles 4MM 32G — HOME AIDE DIAGNOSTICS, INC.
- True-Comfort Safety Pen Needles 5MM 31G — HOME AIDE DIAGNOSTICS, INC.
- True-Comfort Safety Pen Needles 6MM 31G — HOME AIDE DIAGNOSTICS, 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 b8759d22-1901-47de-a298-a660d014b5a8 37 fields · synced May 30, 2026