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The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.
INVO BIOSCIENCE, INC.
P-010
Not in Commercial Distribution
- 00862190000310 ()
- Assisted reproduction procedure dish
The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
General Devices
Rosetta-Lt Data Translator
Not in Commercial Distribution
- 00862186000386 ()
040-184-7100
- Medical networking interface unit
The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
General Devices
CAREpoint Workstation
Not in Commercial Distribution
- 00862186000379 ()
040-183-4000
- Medical networking interface unit
Earscan 3 Automatic Threshold Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3
In Commercial Distribution
- 00862185000325 ()
05.001
- Tone audiometer, automated
Earscan 3 Screening Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3S
In Commercial Distribution
- 00862185000318 ()
04.001
- Tone audiometer, manual
Earscan 3 Manual Audiometer.
MICRO AUDIOMETRICS CORPORATION
ES3M
In Commercial Distribution
- 00862185000301 ()
06.001
- Tone audiometer, manual
Torq ZDrive MR, Ram Scientific
MEDTOX DIAGNOSTICS, INC.
ZZP-MR-RS Rev 0
In Commercial Distribution
- 00862105000374 ()
- General-purpose centrifuge IVD
Torq MiniDrive2
MEDTOX DIAGNOSTICS, INC.
ZZP-MD2-1 Rev 0
In Commercial Distribution
- 00862105000343 ()
- General-purpose centrifuge IVD
Torq ZDrive MR, BD Microtainer
MEDTOX DIAGNOSTICS, INC.
ZZP-MR-1 Rev 0
In Commercial Distribution
- 00862105000336 ()
- General-purpose centrifuge IVD
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.
Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
ACCELERATE DIAGNOSTICS, INC.
10301008
In Commercial Distribution
- 00862011000321 ()
- 10862011000328 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry