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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Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-12
In Commercial Distribution

  • 00850012532231 ()
F-0100-12

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-11
In Commercial Distribution

  • 00850012532224 ()
F-0100-11

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-10
In Commercial Distribution

  • 00850012532217 ()
F-0100-10

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-09
Koya Medical, Inc.
F-0100-09
In Commercial Distribution

  • 00850012532200 ()
F-0100-09

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-08
In Commercial Distribution

  • 00850012532194 ()
F-0100-08

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger Copy
Koya Medical, Inc.
F-0100-07
In Commercial Distribution

  • 00850012532187 ()
F-0100-07

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-06
In Commercial Distribution

  • 00850012532170 ()
F-0100-06

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-05
Koya Medical, Inc.
F-0100-05
In Commercial Distribution

  • 00850012532163 ()
F-0100-05

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-04
In Commercial Distribution

  • 00850012532156 ()
F-0100-04

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-03
In Commercial Distribution

  • 00850012532149 ()
F-0100-03

  • Wearable sequential venous compression system
Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-02
In Commercial Distribution

  • 00850012532132 ()
F-0100-02

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-01
Koya Medical, Inc.
F-0100-01
In Commercial Distribution

  • 00850012532125 ()
F-0100-01

  • Wearable sequential venous compression system
Dayspring Charger
Koya Medical, Inc.
F-0006-01
In Commercial Distribution

  • 00850012532118 ()
F-0006-01

  • Wearable sequential venous compression system
Dayspring Controller
Koya Medical, Inc.
F-0002-01
In Commercial Distribution

  • 00850012532101 ()
F-0002-01

  • Wearable sequential venous compression system
Gauntlet, Small
Koya Medical, Inc.
F-0030-01
In Commercial Distribution

  • 00850012532095 ()
F-0030-01

  • Wearable sequential venous compression system
Gauntlet, Medium
Koya Medical, Inc.
F-0030-02
In Commercial Distribution

  • 00850012532088 ()
F-0030-02

  • Wearable sequential venous compression system
Gauntlet, Large
Koya Medical, Inc.
F-0030-03
In Commercial Distribution

  • 00850012532071 ()
F-0030-03

  • Wearable sequential venous compression system
Gauntlet, X-Large
Koya Medical, Inc.
F-0030-04
In Commercial Distribution

  • 00850012532064 ()
F-0030-04

  • Wearable sequential venous compression system
Arm Liner, Large
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532057 ()
F-0020-02

  • Wearable sequential venous compression system
Arm Liner, Medium
Koya Medical, Inc.
F-0020-02
In Commercial Distribution

  • 00850012532040 ()
F-0020-02

  • Wearable sequential venous compression system
Arm Liner, Small
Koya Medical, Inc.
F-0020-01
In Commercial Distribution

  • 00850012532033 ()
F-0020-01

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Long
Koya Medical, Inc.
F-0010-03
In Commercial Distribution

  • 00850012532026 ()
F-0010-03

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Medium
Koya Medical, Inc.
F-0010-02
In Commercial Distribution

  • 00850012532019 ()
F-0010-02

  • Wearable sequential venous compression system
Arm Garmet, Dayspring, Short
Koya Medical, Inc.
F-0010-01
In Commercial Distribution

  • 00850012532002 ()
F-0010-01

  • Wearable sequential venous compression system
MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
Bio-RAD Laboratories, Inc.
25228
Not in Commercial Distribution

  • 00847865002745 ()

  • 50 Tests
25228

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution

  • 00686597010198 ()
90-1019

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
INSTI HIV-1/HIV-2 Control Test
Biolytical Laboratories Inc
90-1031
Not in Commercial Distribution

  • 06865979010313 ()
90-1031

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
HIV-1 Control Test Kit
Biolytical Laboratories Inc
90-1030
Not in Commercial Distribution

  • 06865979010306 ()
90-1030

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Extreme Hydrocolloid blister cushion, all one size, 42 mm x 68 mm
MEIJER, INC.
713733229203
In Commercial Distribution

  • 10713733229200 ()
  • 00713733229203 ()
  • 60713733229205 ()
4300495

  • Exudate-absorbent dressing, hydrophilic-gel, non-sterile
Wart Freezer Cryogenic Treatment 1-Step Wart Remover
MEIJER, INC.
4080389
In Commercial Distribution

  • 10713733086148 ()
  • 00713733086141 ()

  • Height: 155 Millimeter
4080389

  • Wart-removal cryogenic kit
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