Identity
- Trade Name
- VAMP PLUS FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- BLOOD MANAGEMENT SYSTEM FDA UDI
- Model / Reference
- VP2 FDA UDI
- Description
- BLOOD MANAGEMENT SYSTEM FDA UDI
Identifiers
- Catalog Number
- VP2 FDA UDI
- Primary DI / UDI-DI
- 07460691944831 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 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
Dimensions & Sizes
- Size
- Length — 60 Inch FDA UDI
Category: Arterial blood sampling kit
Vamp Plus 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
K181684 also covers:
- TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC
K896819 also covers:
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — Edwards Lifesciences LLC
- TRUWAVE, VAMP — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 9a3acf8a-8054-4c18-ac31-921f10c15473 38 fields · synced Jun 8, 2026