Identity
- Trade Name
- Penlon FDA UDI
- Generic Name
- Enflurane anaesthesia vaporizer FDA UDI
- Device Name
- Anaesthetic vaporizer / Enflurane, use in the MRI environment. FDA UDI
- Model / Reference
- Sigma Delta MRI FDA UDI
- Description
- Anaesthetic vaporizer / Enflurane, use in the MRI environment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051977000536 FDA UDI
- 510(k) Number
- K002343 FDA UDI
- FDA Product Code
- CAD FDA UDI
- GMDN Term
- Enflurane anaesthesia vaporizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5880 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Penlon by Penlon , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Penlon , Ltd.
Sources (1)
- FDA UDI a9b3076b-7a94-4a92-8f93-f925adaf6451 36 fields · synced May 30, 2026