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Found 10 results
510(k) Data Aggregation
K Number
K010420Device Name
RUSCH MMG/O'NEIL CATHETER
Manufacturer
RUSCH, INC.
Date Cleared
2001-05-09
(86 days)
Product Code
FCM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993528Device Name
RUSCH EMERGENCY MASK
Manufacturer
RUSCH, INC.
Date Cleared
2000-05-31
(226 days)
Product Code
CBP, DAT
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.
Device Description
The Rusch Emergency Mask is one-piece, single use, full-sized light weight PVC mask system which includes a universal breathing tube, one way filtered valve, head straps and oxygen port. The design of the ER mask permits it to fold into a convenient pocket sized case for portability yet deploy instantly for use as a CPR Mask when removed from its package. The mask can be supplied with or without examination gloves. The soft PVC cushion promotes a seal to the face allowing ventilation through both the mouth and nose simultaneously. The transparent structure permits visual identification. The mouth piece and the one way valve with 3M Filtrate TM filter provide the rescuer protection when using "mouth-tomouth" rescue techniques. The proximal end of the breathing tube can be attached to a universal resuscitation bag port while the integral oxygen tube allows for connection to an emergency oxygen system.
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K Number
K993194Device Name
RUSCH MANUAL RESUSCITATOR BAG
Manufacturer
RUSCH, INC.
Date Cleared
2000-03-24
(183 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The manual resuscitator is intended for use on patients requiring total or intermittent airway support. Provides positive pressure ventilation and allows spontaneous breathing either with a 22mm inner diameter face mask port or through an artificial airway having a 15mm outer diameter connection.
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
Device Description
The product consists of a face mask, bag, valve, reservoir bag, and tubing with connector for introduction of oxygen enriched air. The valve is made from K-Resin and the other main components mentioned above are made from PVC. The cushion mask is clear to permit easy patient monitoring and is mounted on a 360° swivel for convenience. The bag is textured to give a positive grip.
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K Number
K980870Device Name
RUSCH SILICONE FOLEY CATHETER
Manufacturer
RUSCH, INC.
Date Cleared
1998-06-09
(97 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.
Device Description
The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.
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K Number
K974419Device Name
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
Manufacturer
RUSCH, INC.
Date Cleared
1998-01-27
(64 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra
Device Description
The Rusch Inc. Simplastic Councill Tip Catheter may be supplied as a stand alone device or may be accompanied with accessories including a filiform and follower. The Simplastic Councill Tip Catheter consists of a 2-way PVC Foley catheter with a 5 ml balloon and an open tip to fit over a guide. The catheter can be supplied with a lubricious coating to facilitate insertion. The guide will be a flexible PVC shaft with standard threaded male Philips connector for attachment of a detachable filiform. The filiform also consists of a PVC shaft with a standard threaded female Philips connector. The catheter and accessories are supplied sterile. Sterility is by Ethylene Oxide Sterilization.
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K Number
K963779Device Name
RUSCH ENTERAL FEEDING TUBE
Manufacturer
RUSCH, INC.
Date Cleared
1997-05-23
(245 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Device is intended for introduction into the Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.
Device Description
The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement
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K Number
K970021Device Name
RUSCH SUPRAPUBIC TRAY
Manufacturer
RUSCH, INC.
Date Cleared
1997-02-07
(35 days)
Product Code
KOB
Regulation Number
876.5090Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.
Device Description
The kit consists of two major components: silicone catheter and plastic introducer assembly, along with attachment tape to fix the catheter to the skin, if required, and an optional scalpel. The kit is used for percutaneous bladder drainage. There are two types of silicone catheters. The first comes equip with one pair of drainage eyes. The second type of silicone catheter comes with six drainage eves arranged in a pigtail shape.
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K Number
K963993Device Name
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
Manufacturer
RUSCH, INC.
Date Cleared
1996-12-17
(74 days)
Product Code
FCM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rusch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.
Device Description
The Rusch Simplastic Foley Catheterization Set contains a pack of lubricating jelly and a Rüsch Simplastic Foley Catheter. The Rusch Simplastic Foley Catheters used in the kit will be available: in 2 way and 3 way formats in various sizes from 12 - 26 F.G. in two hardnesses with various sizes of balloon with various tip and eye configurations. Common features of all the catheters are: a clear polyvinyl chloride tube, a radiopaque stripe of BaSO loaded PVC is fully encapsulated in the tube wall, a latex balloon attached by adhesive bonding, a funnel connected to the main lumen and a luer activated valve for filling and emptying the balloon.
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K Number
K955564Device Name
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
Manufacturer
RUSCH, INC.
Date Cleared
1996-06-28
(205 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
Device Description
The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
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K Number
K955495Device Name
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
Manufacturer
RUSCH, INC.
Date Cleared
1996-06-27
(209 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
RUSCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
single use, sterile, cuffed tracheal intubation and indicated for airway management.
Device Description
consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector. The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.
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