Identity
- Trade Name
- BD Luer-Lok, BD Eclipse FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe 5ml LL w/Needle 22x1-1/2in RB FDA UDI
- Model / Reference
- 305785 FDA UDI
- Description
- Syringe 5ml LL w/Needle 22x1-1/2in RB FDA UDI
Identifiers
- Catalog Number
- 305785 FDA UDI
- Primary DI / UDI-DI
- 00382903057856 FDA UDI
- 510(k) Number
- K010188 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- General-purpose syringe/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
Yes
FDA UDI
Over-the-Counter
No
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
- Total Volume — 5 Milliliter FDA UDINeedle Gauge — 22 Gauge FDA UDILength — 1.5 Inch FDA UDI
Category: General-purpose syringe/needle
BD Luer-Lok, BD Eclipse by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe/needle.
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Cleared under the same submission
K010188 also covers:
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
- BD Eclipse — BECTON DICKINSON AND COMPANY
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 62d6a46c-497e-4372-b982-7b4b828e6484 37 fields · synced May 30, 2026