Identity
- Trade Name
- Adjustable Reconstruction Tube FDA UDI
- Generic Name
- Nasopharyngeal airway, single-use FDA UDI
- Device Name
- Esophageal Prosthesis FDA UDI
- Model / Reference
- ERT-14 FDA UDI
- Description
- Esophageal Prosthesis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815347023755 FDA UDI
- FDA Product Code
- KAC FDA UDI
- GMDN Term
- Nasopharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Nasopharyngeal airway, single-use
Adjustable Reconstruction Tube by Hood, E Benson Laboratories Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasopharyngeal airway, single-use.
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- BM Nasopharyngeal Airways — Bonree Medical Co., Ltd. · Class I
- Shiley — Covidien LP · Class I
- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Shiley — Covidien LP · Class I
- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
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
- Hood, E Benson Laboratories Inc
Sources (1)
- FDA UDI 425657ad-2eae-45c4-8095-28cccda1a2b1 33 fields · synced May 30, 2026