INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory (UDI Z-2130-2017)
Manufactured by Teleflex Medical
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.
Enforcement actions are currently active for this product line.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...
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
}
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 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..
Other Devices by Teleflex Medical
- → ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
- → CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
- → WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
- → PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint