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FlexiCap Disconnect Cap with Povidone-Iodine Solution
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- FlexiCap Disconnect Cap with Povidone-Iodine Solution FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine. FDA UDI
- Model / Reference
- 5C4456 FDA UDI
- Description
- This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine. FDA UDI
Identifiers
- Catalog Number
- 5C4456 FDA UDI
- Primary DI / UDI-DI
- 00085412349145 FDA UDI
- FDA Product Code
- KDJ FDA UDI
- GMDN Term
- Peritoneal dialysis system tubing set 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Peritoneal dialysis system tubing set
FlexiCap Disconnect Cap with Povidone-Iodine Solution by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis system tubing set.
- Easy-Lock — Baxter Healthcare Corp · Class II
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- Liberty® — Fresenius Medical Care Holdings, Inc. · Class II
- MiniCap — Baxter Healthcare Corp · Class II
- VersiPD — Fresenius Medical Care Holdings, Inc. · Class II
- Liberty® PDx — Fresenius Medical Care Holdings, Inc. · Class II
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
- Baxter International Inc.
Sources (1)
- FDA UDI de85ade5-d29d-4a20-9209-0827c9f8d51c 36 fields · synced Jun 8, 2026