Identity
- Trade Name
- 5" 15MM ULTRA FLEX® TUBING FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Note: 203-301-011-D is new part number for 203-301-011 REV D. Product did not change. FDA UDI
- Model / Reference
- 203-301-011-D FDA UDI
- Description
- Note: 203-301-011-D is new part number for 203-301-011 REV D. Product did not change. FDA UDI
Identifiers
- Catalog Number
- 203-301-011-D FDA UDI
- Primary DI / UDI-DI
- 00612649185392 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia breathing circuit, single-use
5" 15mm Ultra Flex® Tubing by King Systems Corporation. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e7677cf1-b326-4b3c-af61-94396e8043db 35 fields · synced May 30, 2026