CYCLER DRAINAGE BAG (UDI 5C4145NS)
Manufactured by BAXTER HEALTHCARE CORPORATION
Device Regulatory Overview
The CYCLER DRAINAGE BAG (Model/Catalog Number: 5C4145NS) is a medical device manufactured by BAXTER HEALTHCARE CORPORATION. This product is indexed under FDA Product Code / Category Classification KDJ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 5C4145NS
- Product Code / EMDN
- KDJ
- 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.
- Database Sync Date
- 2026-08-09 09:08:43
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of CYCLER DRAINAGE BAG?
The registered manufacturer of record for CYCLER DRAINAGE BAG is BAXTER HEALTHCARE CORPORATION.
What is the Primary UDI-DI identifier for CYCLER DRAINAGE BAG?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5C4145NS.
What classification code is assigned to this device?
This device is registered under product classification code KDJ.
Similar Classification Devices (KDJ)
Other Devices by BAXTER HEALTHCARE CORPORATION
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