Identity
- Trade Name
- TRACHEOSTOMY and SUCTION ACCESSORY FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- Sunset Oropharyngeal Airway, Guedel, Soft, 30mm, Size 0 FDA UDI
- Model / Reference
- AOP300GS FDA UDI
- Description
- Sunset Oropharyngeal Airway, Guedel, Soft, 30mm, Size 0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530094850 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Oropharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 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: Oropharyngeal airway, single-use
TRACHEOSTOMY and SUCTION ACCESSORY by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RUSCH — TELEFLEX INCORPORATED · Class I
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- RUSCH — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX 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 21c2411a-b8ee-4492-9520-c58730c50560 34 fields · synced May 31, 2026