Identity
- Trade Name
- Shiley FDA UDI
- Generic Name
- Nasopharyngeal airway, single-use FDA UDI
- Device Name
- Nasopharyngeal Airway FDA UDI
- Model / Reference
- 8888247023 FDA UDI
- Description
- Nasopharyngeal Airway FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60884521133087 FDA UDI
- 510(k) Number
- K760125 FDA UDI
- FDA Product Code
- BTQ FDA UDI
- GMDN Term
- Nasopharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5100 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6.5 Millimeter FDA UDICatheter Gauge — 26 French FDA UDI
Category: Nasopharyngeal airway, single-use
Shiley by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasopharyngeal airway, single-use.
- Naso-Pharyngeal Airway — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- Nasopharyngeal Airways — Tianjin Medis Medical Device Co., Ltd. · Class I
- BM Nasopharyngeal Airways — Bonree Medical Co., Ltd. · Class I
- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Adjustable Reconstruction Tube — HOOD, E BENSON LABORATORIES INC · Class I
- Sterile Nasopharyngeal Airway — Shaoxing Jiancheng Medical Products Co., Ltd. · Class I
Cleared under the same submission
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
- Covidien LP
Sources (1)
- FDA UDI 6cd99d11-6dca-4dc4-bca3-bff1a7d7413a 36 fields · synced May 30, 2026