Identity
- Trade Name
- Anesthesia FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
- Device Name
- Sunset Endotracheal Tube, Cuffed (Low Volume), 5.5mm, DEHP-Free FDA UDI
- Model / Reference
- AET1055C FDA UDI
- Description
- Sunset Endotracheal Tube, Cuffed (Low Volume), 5.5mm, DEHP-Free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530094010 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Inspiratory/expiratory limb respiratory tubing, single-use
Anesthesia by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 22MM FLEXTUBE, CUFFED AT 150MM — Intersurgical Incorporated · Class I
- Transcend — SOMNETICS INTERNATIONAL, INC · Class I
- Transcend — SOMNETICS INTERNATIONAL, INC · Class I
- 22MM FLEXTUBE CUFFED 50M AT 400MM — Intersurgical Incorporated · Class I
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 91c94d90-f8a3-4893-82c1-a4f6fde42e5f 34 fields · synced Jun 8, 2026