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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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Q-RIP to Belt Controller Cable for Alice - B1408592A0

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592A
In Commercial Distribution

  • B1408592A0 ()

  • Length: 48 Inch
8592A

  • Pneumograph

Q-RIP to Belt Controller Cable for Alice - B1400573A0

Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0573A
In Commercial Distribution

  • B1400573A0 ()
0573A

  • Electrical-only medical device connection cable, reusable

#LubeLife – Trying to Conceive (TTC) – 2oz - Retail - 00796494420133

Water-Based Personal Lubricant - Retail specific
CC Wellness LLC
42013R
In Commercial Distribution

  • 00796494420133 ()


  • Sexual lubricant

hearX - 00860003469828

hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution

  • 00860003469828 ()


  • Otoscope, direct

Sony - 05714880199420

Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution

  • 05714880199420 ()
21026345

  • Audiometric/hearing device software

CARDINAL HEALTH - 10888439686432

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution

  • 50888439686430 ()
  • 10888439686432 ()
SBA11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Medline - 10080196403905

SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable

CARDINAL HEALTH - 10888439768442

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution

  • 50888439768440 ()
  • 10888439768442 ()
SBA11LLSL2

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Lingo - 00357599849009

Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

CARDINAL HEALTH - 10195594700973

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Panacea - 00092237617694

DS Replacement APP Pad (Double
COMPASS HEALTH BRANDS CORP.
DS-APP2
In Commercial Distribution

  • 30092237617695 ()
  • 00092237617694 ()


  • Alternating-pressure bed mattress overlay, reusable

Panacea - 00092237617687

DS Panacea APP & Pad Syst.,
COMPASS HEALTH BRANDS CORP.
DS-APP1-NADJP
In Commercial Distribution

  • 30092237617688 ()
  • 00092237617687 ()


  • Alternating-pressure bed mattress overlay system

American Bantex - 00092237602232

Genesis Deluxe APP Pump/Pad
COMPASS HEALTH BRANDS CORP.
APP-2000-GBN
In Commercial Distribution

  • 40092237602230 ()
  • 00092237602232 ()


  • Alternating-pressure bed mattress overlay system

American Bantex - 00092237602225

Genesis standard APP pump/pad
COMPASS HEALTH BRANDS CORP.
APP-1000-GBN
In Commercial Distribution

  • 40092237602223 ()
  • 00092237602225 ()


  • Alternating-pressure bed mattress overlay system

Perifit - 03770014642226

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
Not in Commercial Distribution

  • 03770014642226 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642004

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser

CARDINAL HEALTH - 10195594541880

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00643169738058

SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer

N/A - 00643169738041

SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer

Halo Systems - 05690977308701

J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs

Cell Therapy 360 Wearable Tech V1 - 00851203006265

BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006258

BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006241

BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

GN ReSound - 05708296076703

APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
Not in Commercial Distribution

  • 05708296076703 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296076697

APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
Not in Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296074259

APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
Not in Commercial Distribution

  • 05708296074259 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296074242

APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
Not in Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control

Beltone - 05708296074235

APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
Not in Commercial Distribution

  • 05708296074235 ()


  • Hearing aid/implant system remote control

Beltone - 05708296074228

APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
Not in Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296074211

APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
Not in Commercial Distribution

  • 05708296074211 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296074204

APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
Not in Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071548

APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution

  • 05708296071548 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071531

APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296070831

APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
Not in Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control

Beltone - 05708296070824

APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
Not in Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296070817

APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
Not in Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control

hearX - 00858177007458

IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software

WIDEX - 05706069779707

APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control

N/A - 00763000041618

SW APP A620 DBS PATIENT
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000041618 ()


  • Multiple active implantable device programmer

N/A - 00721902865572

SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution

  • 00721902865572 ()


  • Multi-purpose stereotactic surgery system
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