Identity
- Trade Name
- stay•safe® organizer FDA UDI
- Generic Name
- Peritoneal dialysis manifold, single-use FDA UDI
- Model / Reference
- 030-10807 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102310 FDA UDI
- 510(k) Number
- K173718 FDA UDI
- FDA Product Code
- FKX FDA UDI
- GMDN Term
- Peritoneal dialysis manifold, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peritoneal dialysis manifold, single-use
stay•safe® organizer by Fresenius Medical Care Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K173718 also covers:
- Liberty® — Fresenius Medical Care Holdings, Inc.
- Liberty® — Fresenius Medical Care Holdings, Inc.
- Liberty® — Fresenius Medical Care Holdings, Inc.
- stay•safe® Handi-tool — Fresenius Medical Care Holdings, Inc.
- stay•safe® organizer holder — Fresenius Medical Care Holdings, Inc.
- Liberty — Fresenius Medical Care Renal Therapies Group, LLC
- Liberty — Fresenius Medical Care Renal Therapies Group, LLC
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
- Fresenius Medical Care Holdings, Inc.
Sources (1)
- FDA UDI c02e68df-7539-4995-9d59-848acc92f1e0 34 fields · synced May 30, 2026