Identity
- Trade Name
- CYCLER DRAINAGE BAG FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets. FDA UDI
- Model / Reference
- 5C4145NS FDA UDI
- Description
- The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets. FDA UDI
Identifiers
- Catalog Number
- 5C4145NS FDA UDI
- Primary DI / UDI-DI
- 07332414207939 FDA UDI
- 510(k) Number
- K214016 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
Dimensions & Sizes
- Size
- Total Volume — 15 Liter FDA UDI
Category: Peritoneal dialysis system tubing set
Cycler Drainage Bag by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis system tubing set.
- Safe-Lock® — Fresenius Medical Care Holdings, Inc. · Class II
- stay.safe® — Fresenius Medical Care Holdings, Inc. · Class II
- VersiPD — Fresenius Medical Care Holdings, Inc. · Class II
- Cycler Drainage Bag — BAXTER INTERNATIONAL INC. · Class II
- Manifold Set — BAXTER INTERNATIONAL INC. · Class II
- LOW RECIRCULATION VOLUME APD SET — BAXTER INTERNATIONAL INC. · Class II
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- HOMECHOICE APD SET — BAXTER INTERNATIONAL INC. · Class II
Cleared under the same submission
K214016 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
- Baxter Healthcare Corp
Sources (1)
- FDA UDI cefcdc82-3f2e-4192-acb5-7d73e5a57091 38 fields · synced Jun 8, 2026