Identity
- Trade Name
- ADULT ULTRA FLEX®ANESTHESIA CIRCUIT & PACK KIT FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- ULTRAFLEX CIRCUIT & PACK KIT FDA UDI
- Model / Reference
- 94360 FDA UDI
- Description
- ULTRAFLEX CIRCUIT & PACK KIT FDA UDI
Identifiers
- Catalog Number
- 94360 FDA UDI
- Primary DI / UDI-DI
- 00612649199825 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adult Ultra Flex®anesthesia Circuit & Pack Kit by King Systems Corporation. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- King Systems Corporation.
Sources (1)
- FDA UDI b9a3809b-aefd-4cdb-95d9-a8619f7c0eaa 37 fields · synced May 30, 2026