Identity
- Trade Name
- VAMP Optima FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- VAMP Optima System FDA UDI
- Model / Reference
- VOPTIMA FDA UDI
- Description
- VAMP Optima System FDA UDI
Identifiers
- Catalog Number
- VOPTIMA FDA UDI
- Primary DI / UDI-DI
- 00690103199062 FDA UDI
- 510(k) Number
- K180275 FDA UDI
- FDA Product Code
- FPA FDA UDIFMG FDA UDIKRA FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI870.1210 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
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 84.0000 Inch FDA UDI
Category: Arterial blood sampling kit
VAMP Optima by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180275 also covers:
- FloTrac IQ, VAMP Optima — Edwards Lifesciences LLC
- FloTrac IQ, VAMP Optima — Edwards Lifesciences LLC
- FloTrac IQ, VAMP Optima — Edwards Lifesciences LLC
- FloTrac IQ, VAMP Optima — Edwards Lifesciences LLC
- FloTrac IQ, VAMP Optima, TruWave — Edwards Lifesciences LLC
- FloTrac IQ, VAMP Optima, TruWave — Edwards Lifesciences LLC
- FloTrac, VAMP Optima — Edwards Lifesciences LLC
- FloTrac, VAMP Optima — Edwards Lifesciences LLC
- FloTrac, VAMP Optima — Edwards Lifesciences LLC
- FloTrac, VAMP Optima — Edwards Lifesciences LLC
- FloTrac, VAMP Optima — Edwards Lifesciences LLC
- FloTrac, VAMP Optima, TruWave — Edwards Lifesciences LLC
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 1532f53b-9983-4d11-8b19-faddada0cc0f 38 fields · synced Jun 8, 2026