Identity
- Trade Name
- Aquatec Ocean - Ocean XL Kit Series FDA UDI
- Generic Name
- Basic toilet seat FDA UDI
- Device Name
- Basic US Model Ocean-XL Kit FDA UDI
- Model / Reference
- 1534328 FDA UDI
- Description
- Basic US Model Ocean-XL Kit FDA UDI
Identifiers
- Catalog Number
- 1534328 FDA UDI
- Primary DI / UDI-DI
- 04028698113211 FDA UDI
- FDA Product Code
- INN FDA UDI
- GMDN Term
- Basic toilet seat FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Commercial Distribution
- 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
Category: Basic toilet seat
Aquatec Ocean - Ocean XL Kit Series by Invacare Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 7c075462-bd73-4495-b681-225cfaf3061d 35 fields · synced May 30, 2026