Identity
- Trade Name
- Integra SP VS02 FDA UDI
- Generic Name
- Anaesthesia unit, portable FDA UDI
- Model / Reference
- 00101T2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815871020060 FDA UDI
- 510(k) Number
- K061102 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Anaesthesia unit, portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia unit, portable
Integra SP VS02 by Avante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K061102 also covers:
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
- Avante
Sources (1)
- FDA UDI cabaa2bc-219b-45f6-887f-d4d0e61a558c 34 fields · synced May 30, 2026