Home GUDID 10193494135437 AVANOS
Primary DI 10193494135437
Brand AVANOS
Company Avanos Medical, Inc.
Model 13543
Catalog number FT11X12
Device description ON-Q* Disposable Fluid Tunnelers & Sheaths
Published 2020-06-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name BSO CATHETER, CONDUCTION, ANESTHETIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BSO Catheter, Conduction, Anesthetic Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10193494135437 Package GS1 5 In Commercial Distribution 00193494135430 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10193494135437 10193494135437 00193494135430 00193494135430 193494135430 0193494135430
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, single-use A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
Regulatory Flags# DUNS number 079375431 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00193493001088 SINGLE SHOT EPIDURAL TRAY 120008532 182A273 2026-08-21 00350770006840 CORTRAK* Enteral Access System 120008508 P20-0950 2026-08-21 00350770007922 CORTRAK* Enteral Access System - Reusable Cable 120006252 20-0966 2026-08-21 00350770009094 CORTRAK* Enteral Access System 120008904 20-0950 2026-08-21 00350770009117 CORTRAK* Enteral Access System - Reusable Cable 120008872 20-0966 2026-08-21 00350770007557 CORFLO* Safety PEG Kit 120008662 30-5320 2026-08-14 00350770008868 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004764 BA-S05NC 2026-08-15 00350770008875 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004831 BA-S12NC 2026-08-15 00350770008899 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004839 BA-S60NC 2026-08-15 00350770008912 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004765 BP-S05NC 2026-08-15 00350770008929 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004842 BP-S12NC 2026-08-15 00350770008943 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004847 BP-S60NC 2026-08-15 00350770008967 NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector 120004849 NEO12 2026-08-15 00350770008981 NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector 120004852 NEO60 2026-08-15 00350770009001 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004832 BA-S12NC-S 2026-08-15 00350770009018 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004869 PNM-S12NC 2026-08-15 00350770009032 NEOMED* Oral / Enteral Syringe with ENFit® Connector 120004874 PNM-S35NC 2026-08-15 00812120004895 Game Ready* System 120008544 550500-04 2026-07-31 00812120005076 Game Ready* Full Leg Boot Wrap, Medium 120008563 590923-04 2026-07-31 00812120005113 Game Ready* Ankle Wrap, Large 120008549 590330-04 2026-07-31
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