Identity
- Trade Name
- Ethox Medical FDA UDI
- Generic Name
- Gastric lavage kit FDA UDI
- Device Name
- 36fr Lavage Tubes FDA UDI
- Model / Reference
- 450087500 FDA UDI
- Description
- 36fr Lavage Tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483131145 FDA UDI
- 510(k) Number
- K860599 FDA UDI
- FDA Product Code
- KDH FDA UDI
- GMDN Term
- Gastric lavage kit 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
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
Dimensions & Sizes
- Size
- Catheter Gauge — 36 French FDA UDI
Category: Gastric lavage kit
Ethox Medical by Ethox Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastric lavage kit.
- Bard® Levin Duodenal Tube — C. R. Bard, Inc. · Class II
- Bard® Stomach/Intestinal Tube — C. R. Bard, Inc. · Class II
- Bard® Stomach/Evacuator Tube — C. R. Bard, Inc. · Class II
- Bard® Baker Jejunostomy Catheter — C. R. Bard, Inc. · Class II
- Bard® Levin Duodenal Tube — C. R. Bard, Inc. · Class II
- Bard® Levin Duodenal Tubes — C. R. Bard, Inc. · Class II
- Bard® Stomach/Intestinal Tube — C. R. Bard, Inc. · Class II
- Bard® Levin Tube — C. R. Bard, Inc. · Class II
Cleared under the same submission
K860599 also covers:
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
- Ethox Medical, Llc
Sources (1)
- FDA UDI 64076f0d-3f94-4844-9088-048b7989a023 37 fields · synced May 30, 2026