gudid
Primary ID: 7N8378
ONE-LINK (UDI 7N8378)
Manufactured by BAXTER INTERNATIONAL INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONE-LINK - Primary ID 7N8378
Device Regulatory Overview
The ONE-LINK (Model/Catalog Number: 7N8378) is a medical device manufactured by BAXTER INTERNATIONAL INC.. This product is indexed under FDA Product Code / Category Classification FPA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 7N8378
- Product Code / EMDN
- FPA
- Device Name
- Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Male Luer Lock Adapter with Retractable Collar
- 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 ONE-LINK?
The registered manufacturer of record for ONE-LINK is BAXTER INTERNATIONAL INC..
What is the Primary UDI-DI identifier for ONE-LINK?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7N8378.
What classification code is assigned to this device?
This device is registered under product classification code FPA.
Similar Classification Devices (FPA)
Other Devices by BAXTER INTERNATIONAL INC.
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