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The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings
Biorep Technologies, Inc.
1.0
In Commercial Distribution
- 00861361000241 ()
- 00861361000234 ()
ISA-001
- Irrigation syringe
DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.
MEDIMAGE, INC.
12
In Commercial Distribution
- 00861333000309 ()
- Multidisciplinary medical image management software
One pouched device, 1F002
Safepath Medical, Inc.
1F002
In Commercial Distribution
- 00861298002622 ()
- Silk suture
One pouched device, 1F001
Safepath Medical, Inc.
1F001
Not in Commercial Distribution
- 00861298002608 ()
1F001
- Silk suture
No Description
SOUNDCURE, INC.
900000
In Commercial Distribution
- 00861259000209 ()
- Air-conduction tinnitus masker, in-the-ear
The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
BELL-82380-A
In Commercial Distribution
- 00861122000312 ()
- 10861122000319 ()
BELL-82380-A
- Haematological concentrate system preparation kit, platelet concentration
The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
CELL-80180-A
In Commercial Distribution
- 10861122000302 ()
- 00861122000305 ()
CELL-80180-A
- Haematological concentrate system preparation kit, platelet concentration
Convenience tray for the Macy Catheter.
Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
HOSPI CORPORATION
B
In Commercial Distribution
- 00861003000226 ()
- 10861003000223 ()
MCT-1001
- Gastrointestinal/biliary dilation balloon catheter, non-medicated
Convenience kit for the Macy Catheter.
Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer Lock Syringe, 3ml Exteral/Oral Syringe, 10ml Enteral/Oral Syringe, Macy Catheter Instructions for Use, Macy Catheter Bedside Care Kit Manual, Macy Catheter Medication Sheet (2), 3-Ply Poly Towel, Lubricating Jelly, Nitrile Gloves, Catheter Securing Device.
HOSPI CORPORATION
D
In Commercial Distribution
- 00861003000219 ()
- 10861003000216 ()
MCK-1001
- Gastrointestinal/biliary dilation balloon catheter, non-medicated
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution
- 00861003000202 ()
MAC-1001
- Gastrointestinal/biliary dilation balloon catheter, non-medicated
Ova1® is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Ova1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.
Aspira Women's Health Inc.
3.0.3.006
In Commercial Distribution
- 00860942000113 ()
- Medical equipment clinical data interfacing software
The Overa® test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The Overa® test is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation. The Overa® test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.
Aspira Women's Health Inc.
4.0.0
In Commercial Distribution
- 00860942000106 ()
- Medical equipment clinical data interfacing software
MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution
- 00860175002403 ()
- Radiation therapy software
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Steth IO
1.0
In Commercial Distribution
- 00860135001958 ()
- Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution
- 00860135001934 ()
- Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 7+ or 8+
Steth IO
iPhone 7+/8+
In Commercial Distribution
- 00860135001927 ()
- Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 7 or 8
Steth IO
iPhone 7/8
In Commercial Distribution
- 00860135001910 ()
- Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 6
Steth IO
iPhone 6
In Commercial Distribution
- 00860135001903 ()
- Electronic acoustic stethoscope
No Description
WORK INCORPORATED
2049
Not in Commercial Distribution
- 00860110000303 ()
- Enteral feeding bag/bottle
No Description
AMVENTUREX, INC.
S11007
In Commercial Distribution
- 00860060002341 ()
- Ketone (acetoacetate) IVD, kit, spectrophotometry
No Description
AMVENTUREX, INC.
S5800335
In Commercial Distribution
- 00860060002334 ()
- Ketone (acetoacetate) IVD, control
No Description
AMVENTUREX, INC.
S5640791
In Commercial Distribution
- 00860060002327 ()
- Ketone (acetoacetate) IVD, reagent
No Description
AMVENTUREX, INC.
s11006
In Commercial Distribution
- 00860060002310 ()
- Ketone (acetoacetate) IVD, kit, spectrophotometry
No Description
GLYTEC, LLC
None
In Commercial Distribution
- 00860057000305 ()
- Infusion pump medication-dosage application software
THE EMERGENCY ELASTIC WRAP - 4"
EINSTEIN WORKS, LLC
1
In Commercial Distribution
- 00860017001298 ()
- Pressure bandage, non-latex, single-use
No Description
Color Diagnostics, LLC
1.0
In Commercial Distribution
- 00860014139314 ()
- General specimen container IVD, additive/medium
No Description
Color Diagnostics, LLC
1.0
In Commercial Distribution
- 00860014139307 ()
- Specimen stabilization reagent IVD
- Oral/respiratory tract specimen container IVD, additive/medium
Buttress Support Plate (Long)
MCCONNELL ORTHOPEDIC MFG. CO.
15-150
In Commercial Distribution
- 00860013953522 ()
15-150
- Operating table torso positioner
Buttress Support Plate (Standard)
MCCONNELL ORTHOPEDIC MFG. CO.
15-100
In Commercial Distribution
- 00860013953515 ()
15-100
- Operating table torso positioner
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution
- 00860013939021 ()
- Transcervical artificial larynx
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution
- 00860013939014 ()
- Transcervical artificial larynx
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution
- 00860013939007 ()
- Transcervical artificial larynx
Tendon Seam™ Magazine - 4 Anchor
Integrity Orthopaedics, Inc
901004
In Commercial Distribution
- 00860013905989 ()
901004
- Tendon/ligament bone anchor, non-bioabsorbable
Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
901005
In Commercial Distribution
- 00860013905972 ()
901005
- Orthopaedic inorganic implant inserter/extractor, single-use
- Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution
- 00860013905965 ()
902001
- Orthopaedic inorganic implant inserter/extractor, single-use
Tendon Seam™ Magazine - 4 Anchor, included with Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
901001
In Commercial Distribution
- 00860013905958 ()
901001
- Tendon/ligament bone anchor, non-bioabsorbable
Tendon Seam™ Magazine - 8 Anchor
Integrity Orthopaedics, Inc
901002
In Commercial Distribution
- 00860013905941 ()
901002
- Tendon/ligament bone anchor, non-bioabsorbable
Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
901003
In Commercial Distribution
- 00860013905934 ()
901003
- Orthopaedic inorganic implant inserter/extractor, single-use
- Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution
- 00860013905927 ()
902001
- Orthopaedic inorganic implant inserter/extractor, single-use
Tendon Seam™ Magazine - 8 Anchor, included with Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
901001
In Commercial Distribution
- 00860013905910 ()
901001
- Tendon/ligament bone anchor, non-bioabsorbable
Sterile Empty EVA Pillow Bag, 5000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0500
In Commercial Distribution
- 00860013851279 ()
- 10860013851276 ()
IFP-17G-0500
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 4000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0400
In Commercial Distribution
- 00860013851262 ()
- 10860013851269 ()
IFP-17G-0400
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 3000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0300
In Commercial Distribution
- 00860013851255 ()
- 10860013851252 ()
IFP-17G-0300
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 2000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0200
In Commercial Distribution
- 00860013851248 ()
- 10860013851245 ()
IFP-17G-0200
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 1000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0100
In Commercial Distribution
- 00860013851231 ()
- 10860013851238 ()
IFP-17G-0100
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 500 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0050
In Commercial Distribution
- 00860013851224 ()
- 10860013851221 ()
IFP-17G-0050
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 250 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0025
In Commercial Distribution
- 00860013851217 ()
- 10860013851214 ()
IFP-17G-0025
- Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 150 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0015
In Commercial Distribution
- 00860013851200 ()
- 10860013851207 ()
IFP-17G-0015
- Intravenous administration bag/bottle
NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165221
In Commercial Distribution
- 00860013746414 ()
- Weight: 300 Gram
- Diagnostic spirometer, professional
NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.
The device is designed for children greater than five years of age, adolescent and adult subjects.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165253
In Commercial Distribution
- 00860013746407 ()
- Weight: 300 Gram
- Expiratory peak flow meter, digital