GUDIDData
gudid Primary ID: CL10051001

Crit-Line (UDI CL10051001)

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 Crit-Line - Primary ID CL10051001

Device Regulatory Overview

The Crit-Line (Model/Catalog Number: CL10051001) is a medical device manufactured by Fresenius Medical Care Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification KOC 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
CL10051001
Product Code / EMDN
KOC
Device Name
Blood Volume Monitor
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 Crit-Line?

The registered manufacturer of record for Crit-Line is Fresenius Medical Care Holdings, Inc..

What is the Primary UDI-DI identifier for Crit-Line?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CL10051001.

What classification code is assigned to this device?

This device is registered under product classification code KOC.

Programmatic Export

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

JSON API Endpoint