Identity
- Trade Name
- System One FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- System One Performance Tubing, 6 ft, 15mm FDA UDI
- Model / Reference
- System One Performance Tubing, 6 ft, 15mm FDA UDI
- Description
- System One Performance Tubing, 6 ft, 15mm FDA UDI
Identifiers
- Catalog Number
- 1074400 FDA UDI
- Primary DI / UDI-DI
- 00606959004702 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Ventilator 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator breathing circuit, single-useVentilator breathing circuit, reusable
System One by Respironics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, reusable.
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- KC 048-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 036-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 018-P - 15mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- RESMED — RESMED PTY LTD · Class I
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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
- Respironics, Inc.
Sources (1)
- FDA UDI 9d9f3a05-fbb4-48f1-9def-24c8a392d911 36 fields · synced May 29, 2026