FDA Registration
Active
🇩🇪 Germany
RHENUS SE & CO. KG
Reg #: 3014656749
·
FEI: 3014656749
·
Expires 2026
Products
45
Proprietary Names
80
Establishment Types
1
Classifications
45
Registration Details
- Registration Name
- RHENUS SE & CO. KG
- Registration Number
- 3014656749
- FEI Number
- 3014656749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rhenus Platz 1
- City
- Holzwickede North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K161075
- PMA Number
- P160025
Owner / Operator
- Firm Name
- Rhenus SE & Co. KG
- Operator Number
- 10057982
- Address
- Elisabeth-Selbert-Strasse 3
- City
- Rodgau
- State
- Hesse
- Postal Code
- 63110
- Country
- DE
- Correspondent
- Christopher Hans Essig
US Agent
- Business Name
- Teleflex Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2018-06-26 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2018-06-25 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2022-03-17 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2018-06-26 |
| Tube, Bronchial (W/Wo Connector) | BTS | Class 2 | Anesthesiology | No | 2018-06-25 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2018-06-25 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2018-06-22 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2018-06-26 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2026-05-05 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2026-05-05 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2018-06-25 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2026-05-05 |
| Coronary Covered Stent | NIV | Class f | Unknown | No | 2026-05-05 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2018-06-26 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-06-25 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2018-06-26 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2026-05-05 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2018-06-25 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2018-06-26 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2026-05-05 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2018-06-25 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2026-05-05 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2026-05-05 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2018-06-25 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2018-06-25 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2018-06-26 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2018-06-26 |
| Stethoscope, Esophageal | BZW | Class 1 | Anesthesiology | No | 2018-06-26 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2018-06-25 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2018-06-26 |
| Catheter, Rectal | GBT | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
| Catheter, Suprapubic (And Accessories) | KOB | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2018-06-25 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2026-05-05 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2018-06-26 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2018-06-25 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2018-06-25 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2026-05-05 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2018-06-25 |
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;
Sengstaken Blakemore Tube - 3 Lumen;
EquipLED; Rusch LiteSlim; DispoLED; Dolphin; Fiber Optic Laryngoscope Blades and Handles; GreenLED; Standard Laryngoscop
Rusch Belly Bag;
Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter;
Rectal tube, rubber;
WECK;
MULTIPLE SUPRAPUBIC CA;
LMA Fastrach ETT;
LMA Unique; LMA Supreme; LMA Fastrach ETT SU; LMA ProSeal; LMA Flexible SU;
LMA Fastrach; LMA Classic Excel; LMA Gastro Cuff Pilot; LMA Classic; LMA Flexible; LMA Fastrach ETT;
Rusch Rectal Tube rubber, Nordmann patter, cylindrical;
LMA Unique Evo; LMA Gastro Cuff Pilot; LMA Flexible PreCurved; LMA Flexible PreCurved Cuff Pilot; MADgic Airway
LMA Unique (Silicone Cuff); LMA Unique (Silicone Cuff) Cuff Pilot; LMA Unique PreCurved; LMA Classic; LMA Unique Evo Cuf
LMA ProSeal Cuff Deflator; Oropharyngeal Guedel Tube Black; LMA Supreme Plus Pack; LMA Protector Cuff Pilot;
LMA Unique (S); LMA Flexible (S); LMA Fastrach Stabiliser Rod; LMA Flexible (S) Cuff Pilot; LMA Unique (S) Cuff Pilot;
LMA Protector; LMA Classic Excel; LMA Fastrach; LMA Flexible (SU); LMA ProSeal; LMA Flexible;
LMA Supreme; LMA Unique PreCurved Cuff Pilot;
LMA ProSeal Introducer; LMA NovaPlus; LMA Fastrach (SU); LMA Cuff-Deflator; LMA Unique;
Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter;
Passeo-18
Nasopharyngeal tube rubber, Wendl pattern;
Catheter Plug, Blunt;
Arrow Arterial Catheterization Set;
PRO-Kinetic Energy
Arrow Thermodilution CathetersInfusion Port Thermodilution
Laser Resistant Tube;
Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter;
Establishment Types
Export Device to the United States But Perform No Other Operation on Device