GUDIDData
gudid Primary ID: AMS-8526CP-2

VYGON (UDI AMS-8526CP-2)

Manufactured by Vygon Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VYGON - Primary ID AMS-8526CP-2

Device Regulatory Overview

The VYGON (Model/Catalog Number: AMS-8526CP-2) is a medical device manufactured by Vygon Corporation. This product is indexed under FDA Product Code / Category Classification OFK 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-1802-2012 View Full Alert →

Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the p...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1798-2012 View Full Alert →

Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syri...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1799-2012 View Full Alert →

Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syri...

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

Technical Specifications

Model Number
AMS-8526CP-2
Product Code / EMDN
OFK
Device Name
CENTRAL LINE KIT
Database Sync Date
2026-08-09 09:35:45

Full Regulatory Attributes

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

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Frequently Asked Questions

Who is the primary manufacturer of VYGON?

The registered manufacturer of record for VYGON is Vygon Corporation.

What is the Primary UDI-DI identifier for VYGON?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is AMS-8526CP-2.

What classification code is assigned to this device?

This device is registered under product classification code OFK.

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