Identity
- Trade Name
- Ameritus FDA UDI
- Generic Name
- Nasogastric/orogastric tube FDA UDI
- Device Name
- 4fr 80cm feeding tube FDA UDI
- Model / Reference
- AEG-40P-80 FDA UDI
- Description
- 4fr 80cm feeding tube FDA UDI
Identifiers
- Catalog Number
- AEG-40P-80 FDA UDI
- Primary DI / UDI-DI
- 10817522011080 FDA UDI
- 510(k) Number
- K100526 FDA UDI
- FDA Product Code
- FPD FDA UDI
- GMDN Term
- Nasogastric/orogastric tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 10 French FDA UDI
Category: Nasogastric/orogastric tube
Ameritus by Kentec Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasogastric/orogastric tube.
- Salem Sump — Cardinal Health 200, LLC · Class II
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- VYGON — Vygon Corp. · Class II
- Aquarius — DEGANIA SILICONE LTD · Class II
- AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. — ANDERSEN PRODUCTS, INC. · Class II
- Maglinte — COOK INCORPORATED · Class II
- Vesco Medical Pediatric Nasogastric Feeding Tubes — CAIR LGL · Class II
- AN11.05 - 16 Fr. Nasogastric Tube (5-lang) (Box 10 Ct.) — ANDERSEN PRODUCTS, INC. · Class II
Cleared under the same submission
K100526 also covers:
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Kentec Medical, Inc.
Sources (1)
- FDA UDI 9d318828-3eb9-4306-a261-da7f47f25b56 37 fields · synced May 30, 2026