GUDIDData
enforcement Primary ID: Z-2130-2017

INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory (UDI Z-2130-2017)

Manufactured by Teleflex Medical

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory - Primary ID Z-2130-2017

Device Regulatory Overview

The INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory (Model/Catalog Number: Unspecified) is a medical device manufactured by Teleflex Medical. This product is indexed under FDA Product Code / Category Classification Product Code: PE103, Lot numbers: 02B1300991, 02B1402029, 02C1301654, 02E1201155, 02H1302224, 02K1100520, 02K1103125, 02K1200732, 02K1202185, 02L0701465, 02L0701959, 02L1201668, 02L1203112, 02M1201149, 74A1601005 & 74F1400876.74H1601152, 74J1601641, 74K1501590 & 74L1500555. 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-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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

Technical Specifications

Model Number
N/A
Device Name
INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
Database Sync Date
2026-08-09 10:06:36

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 INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory?

The registered manufacturer of record for INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory is Teleflex Medical.

What is the Primary UDI-DI identifier for INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2130-2017.

What classification code is assigned to this device?

This device is registered under product classification code Product Code: PE103, Lot numbers: 02B1300991, 02B1402029, 02C1301654, 02E1201155, 02H1302224, 02K1100520, 02K1103125, 02K1200732, 02K1202185, 02L0701465, 02L0701959, 02L1201668, 02L1203112, 02M1201149, 74A1601005 & 74F1400876.74H1601152, 74J1601641, 74K1501590 & 74L1500555..

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