BD Vacutainer Eclipse Signal Blood Collection Needle
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Vacutainer Eclipse EUDAMEDBD Vacutainer® Eclipse™ Blood Collection Needle FDA UDIBD Vacutainer® Eclipse™ Blood Collection Needle Pre-Attached Holder FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Device Name
- BD Vacutainer® Eclipse™ Blood Collection Needle EUDAMEDBecton Dickinson and Company, USA 22G x 1 1/4 FDA UDIBD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder 21G x 1 1/4 FDA UDINEEDLE ECLIPSE 22X1.25 CE FDA UDI
- Model / Reference
- 368608 EUDAMEDFDA UDI368650 EUDAMEDFDA UDI368610 EUDAMEDFDA UDI
- Description
- Becton Dickinson and Company, USA 22G x 1 1/4 FDA UDIBD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder 21G x 1 1/4 FDA UDINEEDLE ECLIPSE 22X1.25 CE FDA UDI
Identifiers
- Catalog Number
- 368608 FDA UDI368650 FDA UDI368610 FDA UDI
- Primary DI / UDI-DI
- 30382903686088 EUDAMEDFDA UDI50382903686501 EUDAMEDFDA UDI30382903686101 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290CWPSTZHHLR EUDAMED
- Unit of Use DI
- 00382903686087 EUDAMED00382903686100 EUDAMED00382903686506 EUDAMED
- FDA Product Code
- FMI FDA 510(k)FDA UDI
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Non-fixed blood collection needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The BD Vacutainer Eclipse Signal Blood Collection Needle is a safety-engineered, multi-sample blood collection needle designed for venipuncture procedures. It incorporates a visible flash signal to confirm proper needle placement within the vein, enhancing procedural confidence and efficiency.
This device is intended for single-use in clinical settings and is supplied sterile. It features a one-handed activation safety shield to reduce the risk of needlestick injuries post-procedure. Authorized under FDA 510(k) clearance and MDR compliance, the needle is categorized under product code FMI for general hospital use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Vacutainer® Eclipse™ blood collection needle | BD, Becton Dickinson – Wikipedia, BD Vacutainer Eclipse™ Signal™ Blood Collection Needles
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170824 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (7)
- FDA 510(k) K170824 24 fields · synced Sep 18, 2026
- FDA UDI 5451bd8e-7edc-4628-9b05-d84080768fa5 36 fields · synced May 29, 2026
- FDA UDI aeaec3b9-e722-41e8-ac2e-1cea6d13b693 36 fields · synced May 30, 2026
- FDA UDI b8519664-fc3a-4618-bf14-5b6e88a3f9e8 36 fields · synced May 30, 2026
- EUDAMED f06935ad-db4f-4acd-a508-4421aa5e7a48 61 fields · synced Jul 8, 2026
- EUDAMED 5db60b7d-f6f8-4604-a16b-337b18d62bf6 61 fields · synced Jul 10, 2026
- EUDAMED d8ed7c37-32fd-4e99-99e7-758b16541fba 61 fields · synced Jul 14, 2026