Identity
- Trade Name
- Ritus FDA UDI
- Generic Name
- Peritoneal dialysis catheter adaptor, single-use FDA UDI
- Device Name
- Peritoneal Dialysis Accessory Beta-Cap Adapter FDA UDI
- Model / Reference
- 8814661001 FDA UDI
- Description
- Peritoneal Dialysis Accessory Beta-Cap Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521811133 FDA UDI
- 510(k) Number
- K840815 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peritoneal dialysis catheter adaptor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Peritoneal dialysis catheter adaptor, single-use
Ritus by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter adaptor, single-use.
- Safe-Lock® — Fresenius Medical Care Holdings, Inc. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Peritoneal Dialysis Catheter Adapter — Medionics International , Ltd. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Locking Cap for Peritoneal Dialysis Catheter Adapter — BAXTER INTERNATIONAL INC. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- stay.safe® — Fresenius Medical Care Holdings, Inc. · Class II
Cleared under the same submission
K840815 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 II | Pending data |
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Manufacturer
- Manufacturer
- Mozarc Medical US LLC
Sources (1)
- FDA UDI 571a9641-0944-46dd-91ef-7ec95f2dd3a9 35 fields · synced Jun 8, 2026