Identity
- Trade Name
- Aquatec Ocean Self Propelling Wheel Kit FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Aquatec Ocean Self Propelling Wheel Kit FDA UDI
- Model / Reference
- 16379 FDA UDI
- Description
- Aquatec Ocean Self Propelling Wheel Kit FDA UDI
Identifiers
- Catalog Number
- 16379 FDA UDI
- Primary DI / UDI-DI
- 04028698082548 FDA UDI
- FDA Product Code
- INN FDA UDI
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Aquatec Ocean Self Propelling Wheel Kit by Invacare Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Invacare Corp.
Sources (1)
- FDA UDI ee2cf555-846d-4a3a-9c41-3cda00d440f4 36 fields · synced May 30, 2026