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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
The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements.
Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation.
Each Kit contains:
1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material.
1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water.
1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride.
5 plastic 1 ml syringes
2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)
SIENCO, INC.
900-1318
In Commercial Distribution
- B55890013181 ()
900-1318
- Multiple coagulation factor IVD, control
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
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 1mL 23G×1"
In Commercial Distribution
- 18800109050017 ()
- 08800109050010 ()
- 28800109050014 ()
- 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 LDS syringe 1mL 26G×1"
In Commercial Distribution
- 18800109001590 ()
- 08800109001593 ()
- 28800109001597 ()
- 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 LDS syringe 1mL 25G×1"
In Commercial Distribution
- 18800109001583 ()
- 08800109001586 ()
- 28800109001580 ()
- General-purpose syringe, single-use