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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eSwallow
COMPASS HEALTH BRANDS CORP.
ESW-9010
Not in Commercial Distribution

  • 80092237618246 ()
  • 00092237618240 ()
  • 01092237618249 ()


  • Transcutaneous electrical stimulation electrode, single-use
Leadwire
COMPASS HEALTH BRANDS CORP.
WQ8110-SNGL
Not in Commercial Distribution

  • 80092237618239 ()
  • 00092237618233 ()


  • Transcutaneous electrical stimulation lead
Bantex APP-2000 pump
COMPASS HEALTH BRANDS CORP.
APP-2000-PUMPBN
In Commercial Distribution

  • 30092237618203 ()
  • 00092237618202 ()


  • Alternating-pressure inflator
AN LEGACY PRO PUMP ONLY,
COMPASS HEALTH BRANDS CORP.
APM-AN-8000-LP-PUMP
In Commercial Distribution

  • 30092237618166 ()
  • 00092237618165 ()


  • Alternating-pressure bed mattress overlay system
GENESIS III PUMP FOR
COMPASS HEALTH BRANDS CORP.
APM-AN-8000-G-PUMP
In Commercial Distribution

  • 30092237618111 ()
  • 00092237618110 ()


  • Alternating-pressure inflator
LEGACY XL PUMP ONLY FOR
COMPASS HEALTH BRANDS CORP.
APM-AN-10000-XL-PUMP
In Commercial Distribution

  • 30092237618104 ()
  • 00092237618103 ()


  • Alternating-pressure inflator
Stratus 7.1 220V Pump
COMPASS HEALTH BRANDS CORP.
27300058
In Commercial Distribution

  • 30092237618050 ()
  • 00092237618059 ()


  • Alternating-pressure inflator
Stratus 5.1 220V Pump
COMPASS HEALTH BRANDS CORP.
27300057
In Commercial Distribution

  • 30092237618043 ()
  • 00092237618042 ()


  • Alternating-pressure inflator
Stratus 3.1 220V Pump
COMPASS HEALTH BRANDS CORP.
27300056
In Commercial Distribution

  • 30092237618036 ()
  • 00092237618035 ()


  • Alternating-pressure inflator
Stratus 7.1 110V Pump
COMPASS HEALTH BRANDS CORP.
27300053
In Commercial Distribution

  • 30092237618005 ()
  • 00092237618004 ()


  • Alternating-pressure inflator
DS-ADJP
COMPASS HEALTH BRANDS CORP.
DS-ADJP
In Commercial Distribution

  • 30092237617930 ()
  • 00092237617939 ()


  • Alternating-pressure inflator
DS EX4
COMPASS HEALTH BRANDS CORP.
DS-DQ7000
In Commercial Distribution

  • 10092237617813 ()
  • 00092237617816 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay system
DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system
Lead Wires for Neo Tek Devices
COMPASS HEALTH BRANDS CORP.
WW8000-TP
In Commercial Distribution

  • 80092237617508 ()
  • 00092237617502 ()
  • 01092237617501 ()


  • Transcutaneous electrical stimulation lead
UltraTENS II Leadwire - Single
COMPASS HEALTH BRANDS CORP.
WW6012
In Commercial Distribution

  • 80092237617478 ()
  • 00092237617472 ()


  • Transcutaneous electrical stimulation lead
CX4 & EX4 Clinical Leadwires
COMPASS HEALTH BRANDS CORP.
WQ8110
Not in Commercial Distribution

  • 80092237617386 ()
  • 00092237617380 ()
  • 01092237617389 ()


  • Transcutaneous electrical stimulation lead
78 Clinical Lead Wires
COMPASS HEALTH BRANDS CORP.
WQ8000
Not in Commercial Distribution

  • 80092237617362 ()
  • 00092237617366 ()
  • 01092237617365 ()


  • Transcutaneous electrical stimulation lead
Conductive Ultrasound Gel -
COMPASS HEALTH BRANDS CORP.
LS5266L1
In Commercial Distribution

  • 80092237617270 ()
  • 00092237617274 ()


  • Skin topical coupling gel
Rubber Electrodes, 2.75 x
COMPASS HEALTH BRANDS CORP.
ER2743B2
In Commercial Distribution

  • 80092237617195 ()
  • 00092237617199 ()
  • 01092237617198 ()


  • Transcutaneous electrical stimulation electrode, single-use
APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable
Full Kit Nebulizer Set with mouthpiece, tee adaptor, reservoir, 7’ (2.1 m) supply
COMPASS HEALTH BRANDS CORP.
NEB-ROSKT
In Commercial Distribution

  • 50092237614209 ()
  • 00092237614204 ()


  • Ambulatory nebulizer, non-heated
Nebulizer (Pediatric) with aerosol mask, 7' (2.1 m) supply tube, elastic strap
COMPASS HEALTH BRANDS CORP.
NEB-PEDM
In Commercial Distribution

  • 50092237614193 ()
  • 00092237614198 ()


  • Ambulatory nebulizer, non-heated
Nebulizer (Adult) with aerosol mask, 7' (2.1 m) supply tube, elastic strap
COMPASS HEALTH BRANDS CORP.
NEB-ADLTM
In Commercial Distribution

  • 50092237614186 ()
  • 00092237614181 ()


  • Ambulatory nebulizer, non-heated
InTENSity Select Combo II
COMPASS HEALTH BRANDS CORP.
DI2195
In Commercial Distribution

  • 80092237614163 ()
  • 00092237614167 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
InTENsity IF Combo II
COMPASS HEALTH BRANDS CORP.
DI2738
In Commercial Distribution

  • 80092237614156 ()
  • 00092237614150 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
InTENSity 12
COMPASS HEALTH BRANDS CORP.
DI1212
In Commercial Distribution

  • 00092237614136 ()
  • 80092237614132 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
SierraNeb 2 Neb Compressor
COMPASS HEALTH BRANDS CORP.
NEB-SIERRA
In Commercial Distribution

  • 60092237613926 ()
  • 00092237613924 ()


  • Ambulatory nebulizer, non-heated
LG TEC Multi -
COMPASS HEALTH BRANDS CORP.
DC8420
In Commercial Distribution

  • 80092237613739 ()
  • 00092237613733 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
TheraSonic Conductive Gel, 16oz LC5266CA
COMPASS HEALTH BRANDS CORP.
LS5266
In Commercial Distribution

  • 80092237613265 ()
  • 00092237613269 ()


  • Skin topical coupling gel
TheraSonic Conductive Gel, 8-oz LS5288CA
COMPASS HEALTH BRANDS CORP.
LS5288
In Commercial Distribution

  • 80092237613258 ()
  • 00092237613252 ()


  • Skin topical coupling gel
TheraSonic Conductive Gel, 2-oz LC2828CA
COMPASS HEALTH BRANDS CORP.
LC2828
In Commercial Distribution

  • 80092237613241 ()
  • 00092237613245 ()


  • Skin topical coupling gel
IF 4K - Digital Interferential
COMPASS HEALTH BRANDS CORP.
DN4055
In Commercial Distribution

  • 80092237612855 ()
  • 00092237612859 ()


  • Interferential electrical stimulation system
Mini Stim EMS Device
COMPASS HEALTH BRANDS CORP.
DM1000
Not in Commercial Distribution

  • 80092237612848 ()
  • 00092237612842 ()


  • Physical therapy ultrasound/neuromuscular stimulation system
Garmetrdoe Sock - Universal
COMPASS HEALTH BRANDS CORP.
GU4025
In Commercial Distribution

  • 80092237612794 ()
  • 00092237612798 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Elbow Sleeve
COMPASS HEALTH BRANDS CORP.
GU4017
In Commercial Distribution

  • 80092237612787 ()
  • 00092237612781 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Glove - Universal
COMPASS HEALTH BRANDS CORP.
GU2856
In Commercial Distribution

  • 80092237612770 ()
  • 00092237612774 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode - Shoulder
COMPASS HEALTH BRANDS CORP.
GS9348
In Commercial Distribution

  • 80092237612763 ()
  • 00092237612767 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Neck Brace -
COMPASS HEALTH BRANDS CORP.
GN3278
In Commercial Distribution

  • 80092237612756 ()
  • 00092237612750 ()


  • Transcutaneous electrical stimulation electrode, single-use
Conductive Neck Brace -
COMPASS HEALTH BRANDS CORP.
GN3275
In Commercial Distribution

  • 80092237612749 ()
  • 00092237612743 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Knee Brace
COMPASS HEALTH BRANDS CORP.
GK1517
In Commercial Distribution

  • 80092237612732 ()
  • 00092237612736 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Silver
COMPASS HEALTH BRANDS CORP.
GB3085
In Commercial Distribution

  • 80092237612725 ()
  • 00092237612729 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Silver
COMPASS HEALTH BRANDS CORP.
GB3070
In Commercial Distribution

  • 80092237612718 ()
  • 00092237612712 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - 5XL
COMPASS HEALTH BRANDS CORP.
GB1027
In Commercial Distribution

  • 80092237612701 ()
  • 00092237612705 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - 4XL
COMPASS HEALTH BRANDS CORP.
GB1025
In Commercial Distribution

  • 80092237612695 ()
  • 00092237612699 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - 3XL
COMPASS HEALTH BRANDS CORP.
GB1023
In Commercial Distribution

  • 80092237612688 ()
  • 00092237612682 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - 2XL
COMPASS HEALTH BRANDS CORP.
GB1021
In Commercial Distribution

  • 80092237612671 ()
  • 00092237612675 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - XL
COMPASS HEALTH BRANDS CORP.
GB1017
In Commercial Distribution

  • 80092237612664 ()
  • 00092237612668 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - LG
COMPASS HEALTH BRANDS CORP.
GB1015
In Commercial Distribution

  • 80092237612657 ()
  • 00092237612651 ()


  • Transcutaneous electrical stimulation electrode, single-use
Garmetrode Back Brace Economy - MD
COMPASS HEALTH BRANDS CORP.
GB1012
In Commercial Distribution

  • 80092237612640 ()
  • 00092237612644 ()


  • Transcutaneous electrical stimulation electrode, single-use
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