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510(k) Data Aggregation
K Number
K192468Device Name
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
Manufacturer
Hangzhou Bever Medical Devices Co., Ltd.
Date Cleared
2019-11-27
(79 days)
Product Code
GBM, EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Bever Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
Device Description
The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film. The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types. The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.
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K Number
K111401Device Name
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
Manufacturer
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Date Cleared
2012-07-19
(427 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BEVER™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during mechanical ventilation and anesthesia.
BEVER Evaller Endotracheal Tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the contaminated mucous and subglottic secretion that accumulate above the cuff by continuous or intermittent suctioning.
Device Description
BEVER™ Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm ~10.0 mm in 0.5 mm increments
BEVER™ Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm~9.0 mm in 0.5 mm increments
BEVER™ Endotracheal Tube with cuff (Oral preformed) is available in sizes 4.0mm~10.0mm in 0.5 mm increments
BEVER™ Endotracheal Tube without cuff (Oral preformed) is available in sizes 3.0mm ~9.0mm in 0.5 mm increments
BEVER™ Endotracheal Tube with cuff (Nasal preformed) is available in sizes 5.0mm ~10.0mm in 0.5 mm increments
BEVER™ Endotracheal Tube without cuff (Nasal preformed) is available in sizes 4.0 mm~9.0mm in 0.5 mm increments
BEVER Eva™ Endotracheal tube (Oral) is available in sizes 6.0mm~9.0mm in 0.5mm increments
The BEVER™ Endotracheal Tube made of polyvinyl chloride is sterile, single use device supplied with a standard 15 mm connector. The Endotracheal Tube is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, high volume/low pressure cuff, inflating system (including inflating tube, valve and pilot balloon) and 15mm connector. The uncuffed tube is composed of main tube and 15mm connector. The main tube incorporates a Magill curve, a beveled/hooded tip with Murphy eye and a tip-to-tip radiopaque line to assist in radiographic visualization.
The design of BEVER Evalls Endotracheal tube is based upon the cuffed Endotracheal Tube (Oral/Nasal) with the addition of a third (integral) lumen within the tube. The lumen terminates above the cuff via a 'notch' (evacuation port) which enables the entrance (via suction) of secretions which have pooled above the cuff into the third (suction) lumen. Approximately half way along the tube length the suction lumen is joined to a suction tube which is external to the main tube. The suction tube is joined to the suction lumen in a similar manner to that of the joint between the inflating tube and the inflating lumen. The distal end of the suction tube terminates in a capped Luer connector which can be connected to either suction tubing or a syringe. The Eva™ Endotracheal tube is available in cuffed and for oral use.
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K Number
K111406Device Name
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
Manufacturer
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Date Cleared
2012-07-19
(427 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BEVER™ Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Device Description
BEVER™ Reinforced Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm~10.0 mm in 0.5 mm increments
BEVER™ Reinforced Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm~7.0 mm in 0.5 mm increments
BEVER " Reinforced Endotracheal tube is an Endotracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.
The BEVER™ Reinforced Endotracheal tube is sterile, single use device supplied with a standard 15 mm connector. It is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, cuff, inflating system (including inflating tube, valve and pilot balloon) and 15 mm connector. The uncuffed tube is composed of main tube and 15 mm connector. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.
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K Number
K111405Device Name
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
Manufacturer
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Date Cleared
2012-02-13
(270 days)
Product Code
GBM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BEVER™ intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
Device Description
BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.
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