SEARCH RESULTS FOR: Federal(122 results)
Did you mean Femoral?
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area.
Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution
- W41020AU201P0001 ()
- Area/Surface Area: 50 Square centimeter
- Cultured skin autograft/xenograft
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 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
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
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 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
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 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