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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070
Primed Instruments Inc
8107
In Commercial Distribution

  • M45381070 ()

  • Working Length: 70cm
  • Brush Diameter: 3.0-5.0mm
  • Minimum Channel Size: 2.0mm
8107

  • Endoscope cleaning brush, reusable
The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
LE230
In Commercial Distribution

  • 05060481690638 ()


  • Electromyography telemetric monitoring system transmitter
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution

  • 10860002280704 ()
  • 00860002280707 ()


  • Vision/eye movement analysis system
The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD
AS-915 Anaerobic Tissue Transport Medium - Surgery Pack (ATTM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in a surgical setting. Pre-reduced anaerobically sterilized (PRAS). 8 mL fill volume. 28 x 57 mm screw top vial. Transparent colorless semi-solid medium. 5 tubes per pack.
ANAEROBE SYSTEMS
AS-915
In Commercial Distribution

  • 00810048901432 ()
  • 00810048901425 ()
AS-915

  • Anaerobic transport medium IVD
Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, resistive color touchscreen 18.5 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; Edwards invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094261585 ()
SUR19-LDH-BXXAX

  • Multiple-patient intensive/general healthcare physiologic monitoring system
VeraSens Voice Blood Glucose Meter
i-SENS, Inc.
282442
In Commercial Distribution

  • 10857513006190 ()
  • 00857513006193 ()


  • Home-use/point-of-care glucose analyser IVD, battery-powered
BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo G2.0FW2.1
In Commercial Distribution

  • 00853553005301 ()
KIT00802

  • Home-use/point-of-care glucose analyser IVD, battery-powered
Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)
LIVONGO HEALTH, INC
Livongo
In Commercial Distribution

  • 00853553005240 ()
KIT00423

  • Home-use/point-of-care glucose analyser IVD, battery-powered
Blood Glucose Monitoring System
FORA CARE INC.
Premium V10 BLE
In Commercial Distribution

  • 00816042012716 ()


  • Home-use/point-of-care glucose analyser IVD, battery-powered
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