Identity
- Trade Name
- Avaline Medical NJ LLC FDA UDI
- Generic Name
- Ear canal irrigation syringe FDA UDI
- Device Name
- Ear Suction Ulcer Bulb - Sterile 2oz FDA UDI
- Model / Reference
- VKEBS FDA UDI
- Description
- Ear Suction Ulcer Bulb - Sterile 2oz FDA UDI
Identifiers
- Catalog Number
- VKEBS FDA UDI
- Primary DI / UDI-DI
- 00810124530877 FDA UDI
- FDA Product Code
- JYH FDA UDI
- GMDN Term
- Ear canal irrigation syringe 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
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ear canal irrigation syringe
Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear canal irrigation syringe.
- Ear and Ulcer Syringe — C. R. Bard, Inc. · Class I
- Ear and Ulcer Syringe — C. R. Bard, Inc. · Class I
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- POMEROY EAR SYRINGE — SONTEC INSTRUMENTS, INC. · 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
- Avaline Medical NJ Limited Liability Company
Sources (1)
- FDA UDI 3491b529-2598-406c-8a0d-a5e1b580f07c 35 fields · synced May 31, 2026