GUDIDData
eudamed_udi Primary ID: 00724004620872

AndoFlex Zinc Single (UDI 00724004620872)

Manufactured by Andover Healthcare Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AndoFlex Zinc Single - Primary ID 00724004620872

Device Regulatory Overview

The AndoFlex Zinc Single (Model/Catalog Number: ASP-UB840Z-01) is a medical device manufactured by Andover Healthcare Inc.. This product is indexed under FDA Product Code / Category Classification M03040299 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-1828-2024 View Full Alert →

Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0182-2020 View Full Alert →

Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0181-2020 View Full Alert →

Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap...

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

Technical Specifications

Model Number
ASP-UB840Z-01
Product Code / EMDN
M03040299
Device Name
COFLEX TLC
Database Sync Date
2026-08-09 16:49:03

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 AndoFlex Zinc Single?

The registered manufacturer of record for AndoFlex Zinc Single is Andover Healthcare Inc..

What is the Primary UDI-DI identifier for AndoFlex Zinc Single?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00724004620872.

What classification code is assigned to this device?

This device is registered under product classification code M03040299.

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