Empty Sterile Container (UDI 5C4462)
Manufactured by Vantive US Healthcare LLC
Device Regulatory Overview
The Empty Sterile Container (Model/Catalog Number: 5C4462) is a medical device manufactured by Vantive US Healthcare LLC. This product is indexed under FDA Product Code / Category Classification FKX 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
- 5C4462
- Product Code / EMDN
- FKX
- Device Name
- This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).
- 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 Empty Sterile Container?
The registered manufacturer of record for Empty Sterile Container is Vantive US Healthcare LLC.
What is the Primary UDI-DI identifier for Empty Sterile Container?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5C4462.
What classification code is assigned to this device?
This device is registered under product classification code FKX.
Similar Classification Devices (FKX)
Other Devices by Vantive US Healthcare LLC
Programmatic Export
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JSON API Endpoint