Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014656749

FEI Number

3014656749

Entity Name

RHENUS SE & CO. KG

City/State/Country

Holzwickede North Rhine-Westphalia, DE

Establishment Address

Rhenus Platz 1, Holzwickede North Rhine-Westphalia 59439, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Rhenus SE & Co. KG (Owner Number: 10057982)

Owner / Operator Contact Address

Elisabeth-Selbert-Strasse 3, Rodgau, DE-HE 63110, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944301

PMA Number

N/A

All Registered Proprietary Names

Inflatable Nasal Tube, Masing pattern; 0.2 Micron In-Line Flat Anesthesia Conduction Filter; Sheridan Endotracheal Tube Rusch Pediatric Silicone Foley; Rusch Silicone Foley; Rusch Silicone Tiemann Foley; RUSCH Brillant Silicone Foley catheter, 100ml; Oberto Mouth prop; PILLING; Mouth Gag; RUSCH Brillant Silicone Foley catheter, 80ml; Rusch Single Lumen Bronchial Tube; LMA Classic; Tracheoflex set short with / without Cuff and Phonation; Tracheoflex set short with / without Cuff; Arrow UltraQuik Tuohy Ultrasound Peripheral Nerve Block Needle; Arrow UltraQuik Ultrasound Peripheral Nerve Block Needle; Nelaton-Robinson catheter, cylindrical; Nelaton-Robinson catheter, Tiemann pattern; Rusch all purpose Robinson / Nelation; Rusch Silicone Coated Foley, and pediatric; Rusch all purpose red rubber; ERU Catheter PVC Tiemann Pattern; Female catheter; Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern; 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Marked Spring-Wire Guide with Arrow Advancer; 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set; Standard Connector; Tracheal tube soft rubber; FORTRESS FlexTip Plus Epidural Catheter; Pulsar-18 T3 PAPYRUS Tracheal Tube; RUSCH Miller-Abbott tube; TRACHEAL TUBE; Cleaning Brush; KMEDIC; PILLING; CLEANING; MULTIPLE TRACHEAL T; Rusch MRI; Hudson Anesthesia Circuit Assessories; Corr A Tube; Multiple Ventilator T; Smooth Flo Corr A Tube II; Corr A Flex; Venti RuschFlex, armoured tracheal tube, cuffed; RuschFlex, armoured Tracheal tube; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter ORSIRO MISSION Rusch EZ-Blocker; 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set; Anesthesia Face mask, pediatric; Anesthesia Face mask with / without hook ring, black; Facemask Silicone Neck Band; Tracheoflex set short with / without Cuff and Phonation; Tracheoflex set short with / without Cuff; ASTRON Silkospray; Passeo-35 HP Hands-off Thermodilution Catheters MULTIPLE STERILE URETHRAL CATHET; Rusch Intermittent Insertion Kit; Arrow StimuQuik Insulated Peripheral Nerve Block Needle; Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle; CPRAM Respiratory Assist Device; Y Connector Elbow Connector M Connector Connector; Rusch Connector Oxygenator; Rusch Connector with Barbed Elbow; Rusch Connector Trach Tee Fitting; Sher-I-Swiv Double Swivel Connector; Hudson RCI Adaptors and Connectors; Hudson RCI Tubing; Hudson RCI Sensor Tee; Sengstaken Blakemore tube - 4 Lumen, Minnesota Type; Silkobag Rebreathing Bag; REBREATHING; Multiple Rebreathing Bags; Esophageal Stethoscope; REUSABLE BAG MANUAL;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2018-06-26
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-06-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2022-03-17
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-06-25
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2018-06-26
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-06-25
BTS	Tube, Bronchial (W/Wo Connector)	Anesthesiology	Class 2	868.5720	2018-06-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2018-06-25
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-06-22
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-06-25
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-06-26
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2018-06-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2018-06-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2018-06-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-05
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2026-05-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-06-25
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2018-06-25
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2026-05-05
NIV	Coronary Covered Stent	Unknown	Class f	N/A	2026-05-05
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2018-06-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-06-25
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2018-06-26
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2018-06-25
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2018-06-26
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2018-06-22
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-06-25
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2026-05-05
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2018-06-25
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-06-25
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-06-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-06-25
NIO	Stent, Iliac	Unknown	Class 3	N/A	2026-05-05
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2018-06-25
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2026-05-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-05-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-06-25
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2018-06-25
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-06-25
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-06-25
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2018-06-25
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2018-06-26
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-06-25
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2018-06-26
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2018-06-26
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2018-06-25

Official Correspondent

Christopher Hans Essig

US Agent Details

Divya Raman Business: Teleflex Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Rhenus SE & Co. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014656749. Last updated year: 2026. Please use registration number 3014656749 when referencing this establishment in official correspondence.