Identity
- Trade Name
- N Cuvette Segments for BN ProSpec® FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- The N Cuvette Segments are part of the BN ProSpec system. FDA UDI
- Model / Reference
- 10446539 FDA UDI
- Description
- The N Cuvette Segments are part of the BN ProSpec system. FDA UDI
Identifiers
- Catalog Number
- OVLK31 FDA UDI
- Primary DI / UDI-DI
- 00842768012334 FDA UDI
- 510(k) Number
- K001647 FDA UDI
- FDA Product Code
- JZW FDA UDI
- GMDN Term
- Laboratory analyser cuvette IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Laboratory analyser cuvette IVD, single-use
N Cuvette Segments for BN ProSpec® by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K001647 also covers:
- BN II Additive — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- BN ProSpec® System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Cleaner SCS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Control Vials (2.5 mL) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Reagent Vials (5 ml) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 2bbb4fec-130d-480e-8e11-369c7fa9b4c1 36 fields · synced Jun 8, 2026