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The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system.
The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring.
Medical Device Info.
• Class II (enforcement discretion) medical device
• Regulation: Oximeter, 870.2700
• Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
All.health, Inc.
Model 1000
In Commercial Distribution
- 00860010157008 ()
ALGO-m1000-SW (rev 0)
- Pulse oximeter
Additional ultrafiltration unit for AquaA water purification system.
AquaUF 2250 for:
AquaA 1000 & AquaUF 2250
AquaA 2000 & AquaA2 1000 & AquaUF 2250
AquaA 2000 & AquaUF 2250
AquaA 2000 & AquaA2 2000 & AquaUF 2250
AquaA 900H & AquaUF 2250
AquaA 1800H & AquaA2 900H & AquaUF 2250
AquaA 1800H & AquaA2 900H & AquaHT & AquaUF 2250
AquaA 1800H & AquaUF 2250
AquaA 1800H & AquaA2 1800H & AquaUF 2250
AquaA 1800H & AquaA2 1800H & AquaHT & AquaUF 2250
The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system.
The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaUF 2250
In Commercial Distribution
- 04251285200487 ()
- Reverse-osmosis water purification system
Additional ultrafiltration unit for AquaA water purification system.
AquaUF 4000 for:
AquaA 3000 & AquaUF 4000
AquaA 3000 & AquaA2 3000 & AquaUF 4000
AquaA 4000 & AquaUF 4000
AquaA 4000 & AquaA2 4000 & AquaUF 4000
AquaA 2700H & AquaUF 4000
AquaA 2700H & AquaA2 2700H & AquaUF 4000
AquaA 2700H & AquaA2 2700H & AquaHT & AquaUF 4000
AquaA 3600H & AquaUF 4000
AquaA 3600H & AquaA2 3600H & AquaUF 4000
AquaA 3600H & AquaA2 3600H & AquaHT & AquaUF 4000
The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system.
The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaUF 4000
In Commercial Distribution
- 04251285200494 ()
- Reverse-osmosis water purification system
DEVICE DESCRIPTION
The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system
PACKAGING CONTENTS
A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion.
INDICATIONS FOR USE
The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination
DIRECTIONS FOR USE
Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field
Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use
Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure
CONTRAINDICATIONS
The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques
WARNINGS
Contents supplied sterile. Do not use if sterile barrier is damaged
Do not use the GreenEgg™ if the device has been opened or damaged
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician
STORAGE
Store at room temp, avoid extreme temps
DISPOSAL
Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices
REUSE PRECAUTION STATEMENT
For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.
Endoglow, LLC
EP1000-30
In Commercial Distribution
- 00860001161618 ()
- 10860001161615 ()
- Length: 12.5 Inch
- Outer Diameter: 30 Millimeter
EP1000-30
- Colonic bougie
The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.
It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.
The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.
Stimulator, Electrical, Non-implantable, for Incontinence –
Title 21, Code of Federal Regulations Sec.876.5320
ProCode: KPI
Regulation Number: 21 CFR 876.5320
Regulatory Class: II
TENSCARE LIMITED
Kegel Fit 2
In Commercial Distribution
- 05033435134403 ()
K-KEGEL2
- Perineal orifice incontinence-control electrical stimulation system, home-use
The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.
It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.
The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.
Stimulator, Electrical, Non-implantable, for Incontinence –
Title 21, Code of Federal Regulations Sec.876.5320
ProCode: KPI
Regulation Number: 21 CFR 876.5320
Regulatory Class: II
TENSCARE LIMITED
KegelFit2
In Commercial Distribution
- 05033435132089 ()
K-KEGEL
- Perineal orifice incontinence-control electrical stimulation system
AIR SUPPLY
Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
Disposable Models
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3703
In Commercial Distribution
- 10818566019193 ()
- 00818566019196 ()
- Length: 50 Inch
3703
- Patient transfer system, powered
AIR SUPPLY
Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
Disposable Models
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3702
In Commercial Distribution
- 00818566019189 ()
- 10818566019186 ()
- Length: 39 Inch
- Patient transfer system, powered
1. Disposable Syringe
2. Intended use : To inject fluids into or withdraw fluids out of the body.
3. Instructions for use
1) Expose needle by removing needle cover.
2) Inject the fluid into syringe by pulling plunger
3) After injecting the injection fluid into the syringe, inject into disinfected area by pushing plunger.
4) After injecting the fluid into the affected area, withdraw the syringe from needle and dispose immediately("Do not reuse")
4. Warning
1) This product is single use device, therefore it must be disposed after its use
2) Do not reuse after suction the medicines.
3) Do not use individual packages that are opened or damaged because sterilization is not guaranteed.
4) Do not use damaged or bent needle before use.
5) Do not use the product when it finds foreign substances before use
6) To prevent secondary contamination, open the package before use.
7) Do not use the product except general injection purposes.
8) Do not attempt to close the needle cover after use. If you are pierced by contaminated needle, various infections can infected
5. Storage
Avoid direct sunlight and store at room temperature in a dry and clean place.
6. Caution
Federal law restricts this device to sale by or on the order of a physician.
7. Expiry Date : 3 years from manufacturing date
Shinchang Medical Co., Ltd.
Profi disposable syringe 5mL 23G×1"
In Commercial Distribution
- 18800109050611 ()
- 08800109050614 ()
- 28800109050618 ()
- General-purpose syringe, single-use
1. Disposable Syringe
2. Intended use : To inject fluids into or withdraw fluids out of the body.
3. Instructions for use
1) Expose needle by removing needle cover.
2) Inject the fluid into syringe by pulling plunger
3) After injecting the injection fluid into the syringe, inject into disinfected area by pushing plunger.
4) After injecting the fluid into the affected area, withdraw the syringe from needle and dispose immediately("Do not reuse")
4. Warning
1) This product is single use device, therefore it must be disposed after its use
2) Do not reuse after suction the medicines.
3) Do not use individual packages that are opened or damaged because sterilization is not guaranteed.
4) Do not use damaged or bent needle before use.
5) Do not use the product when it finds foreign substances before use
6) To prevent secondary contamination, open the package before use.
7) Do not use the product except general injection purposes.
8) Do not attempt to close the needle cover after use. If you are pierced by contaminated needle, various infections can infected
5. Storage
Avoid direct sunlight and store at room temperature in a dry and clean place.
6. Caution
Federal law restricts this device to sale by or on the order of a physician.
7. Expiry Date : 3 years from manufacturing date
Shinchang Medical Co., Ltd.
Profi disposable syringe 3mL 23G×1"
In Commercial Distribution
- 18800109050413 ()
- 08800109050416 ()
- 28800109050410 ()
- General-purpose syringe, single-use