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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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Biim iOS App, P1.3 - 07090045490181

Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.2 - 07090045490150

Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.2 - 07090045490143

Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.1 - 07090045490020

Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim iOS App, P1.1 - 07090045490013

Biim iOS App, P1.1
Biim Ultrasound AS
P001117
In Commercial Distribution

  • 07090045490013 ()
P001117

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Roscoe Medical - 00092237602058

APP replacement pad, deluxe
COMPASS HEALTH BRANDS CORP.
APP-DLXP
In Commercial Distribution

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable

Roscoe Medical - 00092237602027

APP Replacement pad, basic
COMPASS HEALTH BRANDS CORP.
APP-BPD
In Commercial Distribution

  • 80092237602023 ()
  • 00092237602027 ()


  • Alternating-pressure bed mattress overlay, reusable

HANSATON - 07613389127225

HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software

Meridian Medical - 00815067042562

BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable

UNITRON - 07613389075823

Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software

Seer Home - 09355751001235

Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph

Seer Home - 09355751001051

Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph

Dexcom G7 iOS Watch App - 00386270005168

G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

myAir - 00840193400115

MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software

JO Gelato Mint Chocolate 1oz/30ml - 00851271008031

Water-based Personal Lubricant
CC Wellness LLC
41022
In Commercial Distribution

  • B362410220 ()
  • 00851271008048 ()
  • 00851271008031 ()


  • Sexual lubricant

JO Toy Lube Lubricant2oz/60mL - 00796494420430

Water-Based Personal Lubricant
CC Wellness LLC
42043
In Commercial Distribution

  • 10796494420437 ()
  • 00796494420430 ()


  • Sexual lubricant

JO Toy Lube Lubricant 8oz/240mL - 00796494408438

Water-Based Personal Lubricant
CC Wellness LLC
40843
In Commercial Distribution

  • 10796494408435 ()
  • 00796494408438 ()


  • Sexual lubricant

Shibari - Water-based Aloe Amazon - 8oz / 240mL - 00796494408407

Water-Based Personal Lubricant
CC Wellness LLC
40840-AZ
In Commercial Distribution

  • 10796494408404 ()
  • 00796494408407 ()


  • Sexual lubricant

Shibari - Silicone Lubricant Amazon - 4oz / 120mL - 00796494401651

Silicone-Based Personal Lubricant
CC Wellness LLC
40165-AZ
In Commercial Distribution

  • 10796494401658 ()
  • 00796494401651 ()


  • Sexual lubricant

JO Toy Lube Lubricant 4oz/120mL - 00796494401620

Water-Based Personal Lubricant
CC Wellness LLC
40162
In Commercial Distribution

  • 10796494401627 ()
  • 00796494401620 ()


  • Sexual lubricant

JO Coconut Hybrid 2oz/60mL - 00796494006047

Hybrid-Based Personal Lubricant
CC Wellness LLC
42045
In Commercial Distribution

  • 10796494006044 ()
  • 00796494006047 ()


  • Sexual lubricant

Foil - Wholesale Solutions - Share Satisfaction - Anal Hybrid - 0.33 floz / 10mL - 00796494006016

Hybrid-Based Personal Lubricant
CC Wellness LLC
71119
In Commercial Distribution

  • 10796494006013 ()
  • 00796494006016 ()


  • Sexual lubricant

Foil - Wholesale Solutions - Share Satisfaction - H2O - Original - 0.33 floz / 1 - 00796494006009

Water-Based Personal Lubricant
CC Wellness LLC
71118
In Commercial Distribution

  • 10796494006006 ()
  • 00796494006009 ()


  • Sexual lubricant

Foil - Wholesale Solutions - Share Satisfaction - Premium - Original - 0.33 floz - 00796494005996

Silicone-Based Personal Lubricant
CC Wellness LLC
71117
In Commercial Distribution

  • 10796494005993 ()
  • 00796494005996 ()


  • Sexual lubricant

Foil - JO - Lubricant - Xtra Silky Silicone - 10 mL - 00796494005989

Silicone-Based Personal Lubricant
CC Wellness LLC
79047-IH
In Commercial Distribution

  • 10796494005986 ()
  • 00796494005989 ()


  • Sexual lubricant

Foil - Agape - 10 mL - HMC - 00796494005972

Water-Based Personal Lubricant
CC Wellness LLC
79014
In Commercial Distribution

  • 10796494005979 ()
  • 00796494005972 ()


  • Sexual lubricant

JO - Foil - Xtra Silky - 5mL - HMC - 00796494005965

Silicone-Based Personal Lubricant
CC Wellness LLC
75011
In Commercial Distribution

  • 10796494005962 ()
  • 00796494005965 ()


  • Sexual lubricant

Foil - Agape - 10 mL - HMC - 00796494005958

Water-Based Personal Lubricant
CC Wellness LLC
79063
In Commercial Distribution

  • 10796494005955 ()
  • 00796494005958 ()


  • Sexual lubricant

JO - Foil - Gelato - White Chocolate Raspberry - 10 mL - HMC - 00796494005941

Water-Based Personal Lubricant
CC Wellness LLC
79062
In Commercial Distribution

  • 10796494005948 ()
  • 00796494005941 ()


  • Sexual lubricant

Foil - JO H2O Lubricant - Strawberry - 10mL / 0.34 floz - 00796494005934

Water-Based Personal Lubricant
CC Wellness LLC
79061
In Commercial Distribution

  • 10796494005931 ()
  • 00796494005934 ()


  • Sexual lubricant

Foil - JO Lubricant - Xtra Silky Silicone - 10mL / 0.34 floz - 00796494005927

Silicone-Based Personal Lubriant
CC Wellness LLC
79060
In Commercial Distribution

  • 10796494005924 ()
  • 00796494005927 ()


  • Sexual lubricant

Foil - JO H2O Lubricant - Original - 10mL / 0.34 floz - 00796494005910

Water-Based Personal Lubricant
CC Wellness LLC
79059
In Commercial Distribution

  • 10796494005917 ()
  • 00796494005910 ()


  • Sexual lubricant

Foil - JO Cotton Candy - 10mL / 0.34 floz - 00796494005903

Water-Based Personal Lubricant
CC Wellness LLC
79058
In Commercial Distribution

  • 10796494005900 ()
  • 00796494005903 ()


  • Sexual lubricant

Lubelife - Foil - Water Based- 10 mL - HMC - 00796494005897

Water-Based Personal Lubricant
CC Wellness LLC
79057
In Commercial Distribution

  • 10796494005894 ()
  • 00796494005897 ()


  • Sexual lubricant

Foil - All in One Massage - Warming - 10ml - In House - 00796494005880

Silicone-Based Personal Lubricant
CC Wellness LLC
79019-IH
In Commercial Distribution

  • 10796494005887 ()
  • 00796494005880 ()


  • Sexual lubricant

JO - Foil - Candy Shop - Cotton Candy - 5mL - HMC - 00796494005873

Water-Based Personal Lubricant
CC Wellness LLC
75001
In Commercial Distribution

  • 10796494005870 ()
  • 00796494005873 ()


  • Sexual lubricant

JO - Foil - Cumplay Lubricant - 5ml - 00796494005866

Hybrid-Based Personal Lubricant
CC Wellness LLC
73003
In Commercial Distribution

  • 10796494005863 ()
  • 00796494005866 ()


  • Sexual lubricant

JO - Champagne Flavored Lubricant Foils 3ml - 00796494005859

Water-Based Personal Lubricant
CC Wellness LLC
73002
In Commercial Distribution

  • 10796494005856 ()
  • 00796494005859 ()


  • Sexual lubricant

#Lubelife Foil Thin Silicone 10 mL - 00796494005842

Silicone-Based Personal Lubricant
CC Wellness LLC
70153
In Commercial Distribution

  • 10796494005849 ()
  • 00796494005842 ()


  • Sexual lubricant

#Lubelife - Foil - Anal Silicone - 10 mL - 00796494005835

Silicone-Based Personal Lubricant
CC Wellness LLC
70152
In Commercial Distribution

  • 10796494005832 ()
  • 00796494005835 ()


  • Sexual lubricant

#Lubelife - Foil - Hybrid- 10 mL - 00796494005828

Hybrid-Based Personal Lubricant
CC Wellness LLC
70151
In Commercial Distribution

  • 10796494005825 ()
  • 00796494005828 ()


  • Sexual lubricant

JO Cocktails - Mai Tai Flavored Lubricant - 2 floz 60 mL - 00796494005811

Water-Based Personal Lubricant
CC Wellness LLC
42014
In Commercial Distribution

  • 10796494005818 ()
  • 00796494005811 ()


  • Sexual lubricant

JO Cocktails - Cosmopolitan Flavored Lubricant - 2 floz 60 mL - 00796494005804

Water-Based Personal Lubricant
CC Wellness LLC
42011
In Commercial Distribution

  • 10796494005801 ()
  • 00796494005804 ()


  • Sexual lubricant

LL - Peaches & Cream - 8oz / 240mL - 00796494005781

Water-Based Personal Lubricant
CC Wellness LLC
40842
In Commercial Distribution

  • 10796494005788 ()
  • 00796494005781 ()


  • Sexual lubricant

Pure Romance - Original Flavored Lubricant 4oz/120mL - 00796494005774

Water-Based Personal Lubricant
CC Wellness LLC
74099
In Commercial Distribution

  • 10796494005771 ()
  • 00796494005774 ()


  • Sexual lubricant

Pure Romance - Watermelon Flavored Lubricant 4oz/120mL - 00796494005767

Water-Based Personal Lubricant
CC Wellness LLC
74098
In Commercial Distribution

  • 10796494005764 ()
  • 00796494005767 ()


  • Sexual lubricant

Pure Romance - Strawberry Banana Lubricant 4oz/120mL - 00796494005750

Water-Based Personal Lubricant
CC Wellness LLC
74097
In Commercial Distribution

  • 10796494005757 ()
  • 00796494005750 ()


  • Sexual lubricant

Pink Pussycat - Purrr-fect Lube - 4oz/120ml - 00796494005743

Water-Based Personal Lubricant
CC Wellness LLC
74095
In Commercial Distribution

  • 10796494005740 ()
  • 00796494005743 ()


  • Sexual lubricant

JO - Foil - H2O Anal Thick - Lubricant - 5mL - 00796494005736

Water-Based Personal Lubricant
CC Wellness LLC
73005
In Commercial Distribution

  • 10796494005733 ()
  • 00796494005736 ()


  • Sexual lubricant

JO - Foil - Aloe - Lubricant - 5mL - 00796494005729

Water-Based Personal Lubricant
CC Wellness LLC
73004
In Commercial Distribution

  • 10796494005726 ()
  • 00796494005729 ()


  • Sexual lubricant
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