Identity
- Trade Name
- Aquagel Lubricating Gel EUDAMEDAQUAGEL FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Aquagel Lubricating Gel EUDAMEDAquagel Lubricating Gel, 5 oz. tube FDA UDI
- Model / Reference
- 57-05 EUDAMEDLUBRICATING GEL FDA UDI
- Description
- Aquagel Lubricating Gel, 5 oz. tube FDA UDI
Identifiers
- Catalog Number
- 57-05 FDA UDI
- Primary DI / UDI-DI
- 10855683006361 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300657001KN EUDAMED
- Unit of Use DI
- 00855683006364 EUDAMED
- 510(k) Number
- K864556 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Aquagel Lubricating Gel by Parker Laboratories, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300657001KN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED 3d626b49-20d5-4c2c-b010-e88f0111341b 61 fields · synced Jul 8, 2026
- FDA UDI bed7b017-9660-4692-8edf-b6ba6533364d 36 fields · synced May 30, 2026