Identity
- Trade Name
- AQUAGEL FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- AQUAGEL LUBRICATING GEL 5 OZ TUBE FDA UDI
- Model / Reference
- LUBRICATING GEL FDA UDI
- Description
- AQUAGEL LUBRICATING GEL 5 OZ TUBE FDA UDI
Identifiers
- Catalog Number
- 57-05-1 FDA UDI
- Primary DI / UDI-DI
- 30855683006365 FDA UDI
- 510(k) Number
- K864556 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 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
No
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
Category: Electrode conductive medium
Aquagel by Parker Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K864556 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 I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
Sources (1)
- FDA UDI bff4db1f-c09f-4a51-907d-1dacafb6787b 36 fields · synced May 30, 2026