Identity
- Trade Name
- Vapofil™ FDA UDI
- Generic Name
- Sevoflurane anaesthesia vaporizer FDA UDI
- Device Name
- Vapofil Keyed Anesthetic Agent Adapter Ultane/Sevoflurane FDA UDI
- Model / Reference
- 8907-S FDA UDI
- Description
- Vapofil Keyed Anesthetic Agent Adapter Ultane/Sevoflurane FDA UDI
Identifiers
- Catalog Number
- 8907-S FDA UDI
- Primary DI / UDI-DI
- 10620974001987 FDA UDI
- 510(k) Number
- K843993 FDA UDI
- FDA Product Code
- CAD FDA UDI
- GMDN Term
- Sevoflurane anaesthesia vaporizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5880 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sevoflurane anaesthesia vaporizer
Vapofil™ by Southmedic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K843993 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Southmedic Incorporated
Sources (1)
- FDA UDI 8a78c85e-91f5-4730-89f5-0f520d1957fa 37 fields · synced Jun 6, 2026