GUDIDData
Bulk Audit Tool API Access
gudid Primary ID: 03-2630-6

CombiSet (UDI 03-2630-6)

Manufactured by Fresenius Medical Care Holdings, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CombiSet - Primary ID 03-2630-6

Device Regulatory Overview

The CombiSet (Model/Catalog Number: 03-2630-6) is a medical device manufactured by Fresenius Medical Care Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification FJK within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2702-2026 View Full Alert →

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubi...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2401-2026 View Full Alert →

Bicarby Dialysate; Model number: RFP-400-G;...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2321-2026 View Full Alert →

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
03-2630-6
Product Code / EMDN
FJK
Device Name
Pre-pump, 6.35 mm
Database Sync Date
2026-08-09 09:35:09

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of CombiSet?

The registered manufacturer of record for CombiSet is Fresenius Medical Care Holdings, Inc..

What is the Primary UDI-DI identifier for CombiSet?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03-2630-6.

What classification code is assigned to this device?

This device is registered under product classification code FJK.

Similar Classification Devices (FJK)

Other Devices by Fresenius Medical Care Holdings, Inc.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint