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DiamondCrown-DCBLOK(CADCAM)-I-15mm A1/B1 -
DRM-Laminate/Veneer-Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram
Restorative Materials, Dental Crown & Bridge,
Accessories, Implant Dental - Endosseous,
ZTi-DiamondCrown-Integrated-Implant-Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-15mm A1/B1
In Commercial Distribution
- 00860004379904 ()
DCBK705
- Dental implant suprastructure, permanent, preformed
2 x CPAP PREMIUM UNIVERSAL TUBING (SLIM)6 FOOT 15mm HOSE 22mm CONNECTORS
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001TUB006SS-2
In Commercial Distribution
- 00860004356264 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
Slim CPAP Tube 6ft
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001TUB006SS
In Commercial Distribution
- 00860004356219 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
No Description
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001DSLGPK
In Commercial Distribution
- 00860004356202 ()
- Inspiratory/expiratory limb respiratory tubing, reusable
No Description
Oncospace, Inc.
System
In Commercial Distribution
- 00860004284901 ()
- Radiation therapy software
The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
VITAL ART AND SCIENCE, LLC
Model 0005
Not in Commercial Distribution
- 00860004152705 ()
- Vision testing/training chart
Blood pressure monitor (TMB-1598-BS)
CURA DIGITAL HEALTH SOLUTIONS INC
TMB-1598-BS
In Commercial Distribution
- 00860004114901 ()
- Blood pressure cuff, reusable
17 mm x 28 mm MACI Cutter
VERICEL CORPORATION
82031
In Commercial Distribution
- 00860004093091 ()
N/A
- Surgical implant template, single-use
14 mm x 26 mm MACI Cutter
VERICEL CORPORATION
82030
In Commercial Distribution
- 00860004093084 ()
N/A
- Surgical implant template, single-use
12 mm x 21 mm MACI Cutter
VERICEL CORPORATION
82029
In Commercial Distribution
- 00860004093077 ()
N/A
- Surgical implant template, single-use
17 mm x 28 mm Max Arthroscopic Cutter
VERICEL CORPORATION
82028
In Commercial Distribution
- 00860004093060 ()
N/A
- Bone curette, single-use
14 mm x 26 mm Max Arthroscopic Cutter
VERICEL CORPORATION
82027
In Commercial Distribution
- 00860004093053 ()
N/A
- Bone curette, single-use
12 mm x 21 mm Min arthroscopic cutter
VERICEL CORPORATION
82025
In Commercial Distribution
- 00860004093046 ()
N/A
- Bone curette, single-use
18mm x 4cm Cannula assembly
VERICEL CORPORATION
82018
In Commercial Distribution
- 00860004093039 ()
N/A
- Arthroscopic access cannula, single-use
15mm x 4cm Cannula Assembly
VERICEL CORPORATION
82017
In Commercial Distribution
- 00860004093022 ()
N/A
- Arthroscopic access cannula, single-use
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution
- 00860004081661 ()
- 00860004081654 ()
- 00860004081647 ()
P33-10-MET
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-panel Drug Test Cup
DEUS VULT, LLC
PF12P
Not in Commercial Distribution
- 00860004081609 ()
- 00860004081616 ()
- 00860004081623 ()
- 00860004081630 ()
PF12P
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan. For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under “FDG Medical Imaging Agent Information”.
REFLEXION MEDICAL, INC.
RXM1000
In Commercial Distribution
- 00860003983812 ()
- Linear accelerator system
CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
Cognita Labs, LLC
CAPMED-C
In Commercial Distribution
- 00860003953709 ()
- Inhaler dose sensor
- Diagnostic spirometer, professional
The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm.
The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s).
LOHMAN TECHNOLOGIES, LLC
V2.0
In Commercial Distribution
- 00860003939734 ()
790.102.200
- Electrocardiograph, home-use
The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in four ways: (I) via the two thumb electrodes, (2) by placement on the chest, (3) by applying wrist electrodes or (4) applying two sticky electrodes as instructed by their physician. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.
If AF is indicated, or concerning symptoms are present, the patient can either use a Bluetooth connection to a smart device or use a USB connection to a computer to transfer their ECG data to be viewed and/or shared with their physician.
LOHMAN TECHNOLOGIES, LLC
V1.5
Not in Commercial Distribution
- 00860003939703 ()
- 00860003939710 ()
- 00860003939727 ()
790.0102.001
- Electrocardiograph, home-use
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM03-100
In Commercial Distribution
- 00860003793794 ()
- General tissue specimen container IVD, fixative/saline
- General-purpose absorbent tip applicator/swab, single-use
ASP Oropharyngeal Sterile Specimen Collection Swab 5000 pcs
KEYSTONE MANUFACTURING, LLC
KMSWAB-ASPN-5000
In Commercial Distribution
- 00860003793787 ()
- General-purpose absorbent tip applicator/swab, single-use
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM01-100
In Commercial Distribution
- 00860003793770 ()
- General tissue specimen container IVD, fixative/saline
- General-purpose absorbent tip applicator/swab, single-use
ASP Nasopharyngeal Sterile Specimen Collection Swab 5000pcs
KEYSTONE MANUFACTURING, LLC
KMSWAB-ASPNP-5000
In Commercial Distribution
- 00860003793763 ()
- General-purpose absorbent tip applicator/swab, single-use
Sterile Specimen Collection Polyurethane Foam Swab - 6 inch
KEYSTONE MANUFACTURING, LLC
KMSWAB-1406P-100
In Commercial Distribution
- 10860003793753 ()
- 00860003793756 ()
- General-purpose absorbent tip applicator/swab, single-use
VACUETTE 2ml Virus Stabilization Tube 1200 pcs
KEYSTONE MANUFACTURING, LLC
KMVIAL-VAC2ML-1200
In Commercial Distribution
- 00860003793749 ()
- General tissue specimen container IVD, fixative/saline
VACUETTE 3ml Virus Stabilization Tube 1200 pcs
KEYSTONE MANUFACTURING, LLC
KMVIAL-VAC3ML-1200
In Commercial Distribution
- 00860003793732 ()
- General tissue specimen container IVD, fixative/saline
Sterile Specimen Collection Sterile Polyester Swab - 5 inch
KEYSTONE MANUFACTURING, LLC
KMSWAB-805P-100
In Commercial Distribution
- 10860003793722 ()
- 00860003793725 ()
- General-purpose absorbent tip applicator/swab, single-use
Sterile Specimen Collection Sterile Polyester Swab - 6 inch
KEYSTONE MANUFACTURING, LLC
KMSWAB-806P-100
In Commercial Distribution
- 10860003793715 ()
- 00860003793718 ()
- General-purpose absorbent tip applicator/swab, single-use