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Sample Collection Kit Dried Blood Spot and Kit Accessories
Enable Biosciences Inc.
EBCK1
In Commercial Distribution
- 00860010987803 ()
- Capillary blood collection kit IVD
Single-use convenient serum collection kit includes collection tube(s), and return packing for mailing to testing laboratory.
U.S. Biotek Laboratories LLC
1.0
In Commercial Distribution
- 00860010959268 ()
SCK001
- Evacuated blood collection tube IVD, clot promoter
Robotic prosthetic leg - black - large - robotic knee joint only
BIONICM INC.
SN007
In Commercial Distribution
- 00860010894811 ()
- Mechatronic external knee prosthesis
Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials
BIONICM INC.
BLP001
In Commercial Distribution
- 00860010894804 ()
- Mechatronic external knee prosthesis
No Description
Velmeni Inc.
1.0
In Commercial Distribution
- 00860010893203 ()
V4D
- Dental x-ray image interpretive software
The CarePath system facilitates evaluations measuring urine output. It consists of
the CarePath device, accompanying documents, and training. The system:
• Measures and calculates flow rate and volume from urination data
• Automatically transmits urination data to a secure location
• Creates and provides uroflow reports to healthcare providers
The intended operator of the CarePath device is the patient. The CarePath
system has no user-serviceable components. This system is not to be serviced
or maintained by the user. The intended environments are hospitals, clinics,
doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution
- 00860010862209 ()
- Urine flowmeter, reusable
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.
Kal-Med, LLC
IM-1000
In Commercial Distribution
- 00860010850909 ()
- Artificial airway tube cuff pressure monitor
No Description
Advance-Esthetic LLC
1
In Commercial Distribution
- 00860010841174 ()
111921
- Multi-modality skin surface treatment system
- Dermatological diode laser system
The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.
The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
Wassenburg Medical, Inc.
System 83 Revolve
In Commercial Distribution
- 00860010835241 ()
- Endoscope washer-disinfector (chemical)
Device to flush endoscopes
Wassenburg Medical, Inc.
S8
In Commercial Distribution
- 00860010835227 ()
- Endoscope washer-disinfector (chemical)