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BD Preset™ Eclipse™ Arterial Blood Collection Syringe
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BD Preset™ Eclipse™ Arterial Blood Collection Syringe FDA UDI
- Generic Name
- Blood gas syringe IVD, lithium heparin FDA UDI
- Device Name
- SYR ABG PRESET 3(1.6) LL 23X1 ECLIPSE CE FDA UDI
- Model / Reference
- 364391 FDA UDI
- Description
- SYR ABG PRESET 3(1.6) LL 23X1 ECLIPSE CE FDA UDI
Identifiers
- Catalog Number
- 364391 FDA UDI
- Primary DI / UDI-DI
- 50382903643917 FDA UDI
- 510(k) Number
- K202446 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood gas syringe IVD, lithium heparin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
No
FDA UDI
Category: Blood gas syringe IVD, lithium heparin
BD Preset™ Eclipse™ Arterial Blood Collection Syringe by Becton, Dickinson U.K. Limited — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Blood gas syringe IVD, lithium heparin.
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- BD Preset™ Eclipse™ Arterial Blood Collection Syringe — Becton, Dickinson U.K. Limited · Class II
Cleared under the same submission
K202446 also covers:
- BD A-Line™ Arterial Blood Collection Syringe — Becton, Dickinson U.K. Limited
- BD Preset™ Eclipse™ Arterial Blood Collection Syringe — Becton, Dickinson U.K. Limited
- BD Preset™ Eclipse™ Arterial Blood Collection Syringe — Becton, Dickinson U.K. Limited
- BD Preset™ Eclipse™ Arterial Blood Collection Syringe — Becton, Dickinson U.K. Limited
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 U.K. Limited
Sources (1)
- FDA UDI 3a16162b-c4b6-48e0-a6b3-71973ae6d871 36 fields · synced Jun 1, 2026