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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Supplement Kit (Hong Kong))
ELECTROMED, INC.
SV2100-HKG
In Commercial Distribution

  • B102070124S3440 ()
SV2100-HKG

  • Chest-oscillation airway secretion-clearing system vest
Power Cord, UK, Hong Kong
VENCLOSE INC
VCPCG
In Commercial Distribution

  • 00858254006060 ()


  • Electrical mains power cable
NW Flex System, Hong Kong
NEUWAVE MEDICAL, INC.
NWF2HK1N
Not in Commercial Distribution

  • 00818913020073 ()
NWF2HK1N

  • Microwave ablation system generator
SQL-I Supplement Kit (Hong Kong)
ELECTROMED, INC.
SQL-HKG-I
In Commercial Distribution

  • B102090649S0800 ()
SQL-HKG-I

  • Chest-oscillation airway secretion-clearing system generator
EVERFLO w/Oxygen Percentage Indicator, 230V, Hong Kong
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 230V, HK
Not in Commercial Distribution

  • 00606959032644 ()
1020016

  • Stationary oxygen concentrator
DreamStation Go Auto CPAP with Bluetooth, Hong Kong
Respironics, Inc.
DreamStation Go Auto CPAP with Bluetooth, HK
Not in Commercial Distribution

  • 00606959050181 ()
HKG502S15

  • Home CPAP unit
X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery - Hong Kong
BELLUSCURA PLC
50051-HK-001
In Commercial Distribution

  • 00850029991304 ()


  • Mobile/portable oxygen concentrator
Power supply wall cord (3 Pin, British Style, UK, Hong Kong)
INTEGRA LIFESCIENCES CORPORATION
3539236
In Commercial Distribution

  • M24835392361 ()
  • 10381780277378 ()
3539236

  • Electrical mains power cable
Helix Elite™ Molecular Standards Inactivated Influenza B Virus Strain Hong Kong/5/72
MICROBIOLOGICS INC.
HE0030N
In Commercial Distribution

  • 10845357042047 ()
HE0030N

  • Multiple-genus respiratory virus nucleic acid IVD, control
King Kong Clamp
FUSION ORTHOPEDICS, LLC
TN-AK-0005
In Commercial Distribution

  • 00840124520967 ()
TN-AK-0005

  • Bone approximation clamp
No Description
HONG KONG ETECH GROUPS LIMITED
9029SCM, 9029
In Commercial Distribution

  • 04897139961236 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XXL,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5B-XXL
In Commercial Distribution

  • 04897147760104 ()
  • 04897147760159 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XL,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5B-XL
In Commercial Distribution

  • 04897147760098 ()
  • 04897147760142 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-L,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5B-L
In Commercial Distribution

  • 04897147760081 ()
  • 04897147760135 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-M,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5B-M
In Commercial Distribution

  • 04897147760074 ()
  • 04897147760128 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-S,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5B-S
In Commercial Distribution

  • 04897147760067 ()
  • 04897147760111 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-XXL,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6B-XXL
In Commercial Distribution

  • 04897147760050 ()
  • 04897147760203 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-XL,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6B-XL
In Commercial Distribution

  • 04897147760043 ()
  • 04897147760197 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-L,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6B-L
In Commercial Distribution

  • 04897147760036 ()
  • 04897147760180 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-M,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6B-M
In Commercial Distribution

  • 04897147760029 ()
  • 04897147760173 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable Nitrile Exam Gloves,Heavy Duty 6 Mil-100 Pcs-S,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6B-S
In Commercial Distribution

  • 04897147760012 ()
  • 04897147760166 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 6 Mil-100 Pcs-XXL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6BLUE-XXL
In Commercial Distribution

  • 04897147760302 ()
  • 04897147760258 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 6 Mil-100 Pcs-XL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6BLUE-XL
In Commercial Distribution

  • 04897147760296 ()
  • 04897147760241 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 6 Mil-100 Pcs-L,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6BLUE-L
In Commercial Distribution

  • 04897147760289 ()
  • 04897147760234 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 6 Mil-100 Pcs-M,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6BLUE-M
In Commercial Distribution

  • 04897147760272 ()
  • 04897147760227 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 6 Mil-100 Pcs-S,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG6BLUE-S
In Commercial Distribution

  • 04897147760265 ()
  • 04897147760210 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 5 Mil-100 Pcs-XXL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5BLUE-XXL
In Commercial Distribution

  • 04897147760401 ()
  • 04897147760357 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 5 Mil-100 Pcs-XL,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5BLUE-XL
In Commercial Distribution

  • 04897147760395 ()
  • 04897147760340 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 5 Mil-100 Pcs-L,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5BLUE-L
In Commercial Distribution

  • 04897147760388 ()
  • 04897147760333 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 5 Mil-100 Pcs-M,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5BLUE-M
In Commercial Distribution

  • 04897147760371 ()
  • 04897147760326 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Heavy Duty 5 Mil-100 Pcs-S,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
HONG KONG PROMEDIX COMPANY LIMITED
PMD-HG5BLUE-S
In Commercial Distribution

  • 04897147760364 ()
  • 04897147760319 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Fluid Resistant Procedure Mask - Flat Pleated, Ear Loops, ASTM Level 3, Lavender. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1306
In Commercial Distribution

  • 14897112130069 ()
  • 04897112130062 ()
  • 24897112130066 ()
  • 84897112130068 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask - Flat Pleated, Ear Loops, ASTM Level 3, Yellow. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1305
In Commercial Distribution

  • 14897112130052 ()
  • 04897112130055 ()
  • 24897112130059 ()
  • 84897112130051 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, White. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1304
In Commercial Distribution

  • 14897112130045 ()
  • 04897112130048 ()
  • 24897112130042 ()
  • 84897112130044 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Green. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1303
In Commercial Distribution

  • 14897112130038 ()
  • 04897112130031 ()
  • 24897112130035 ()
  • 84897112130037 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Pink. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1302
In Commercial Distribution

  • 14897112130021 ()
  • 04897112130024 ()
  • 24897112130028 ()
  • 84897112130020 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Blue. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED
LHM-E1301
In Commercial Distribution

  • 04897112130017 ()
  • 14897112130014 ()
  • 24897112130011 ()
  • 84897112130013 ()


  • Surgical/medical face mask, single-use
No Description
United Exchange Corp.
1
In Commercial Distribution

  • 00780707000007 ()


  • Multi-purpose soft contact lens solution
Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C
AED BATTERY EXCHANGE, LLC
G5-ABE
In Commercial Distribution

  • 00864312000284 ()


  • Disposable battery pack
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD AT, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D
AED BATTERY EXCHANGE, LLC
9141-ABE
In Commercial Distribution

  • 00864312000260 ()
9141-ABE

  • Primary battery
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT. Color blue.
AED BATTERY EXCHANGE, LLC
9146-B-ABE
In Commercial Distribution

  • 00864312000246 ()


  • Primary battery
Lithium - Sulfur Dioxide battery for replacement in Lifepak 500(TM) AED.
AED BATTERY EXCHANGE, LLC
500-ABE
In Commercial Distribution

  • 00864312000222 ()


  • Primary battery
Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+
AED BATTERY EXCHANGE, LLC
3863-ABE
In Commercial Distribution

  • 00864312000215 ()


  • Primary battery
Lithium Manganese Dioxide battery for replacement in Philips(TM) Heartstart(TM) FRx Onsite & Home(TM).
AED BATTERY EXCHANGE, LLC
5070-ABE
In Commercial Distribution

  • 00864312000208 ()


  • Primary battery
Lithium Manganese Dioxide battery for use in Philips(TM) HeartStart(TM) FR3 AED's 861388 and 861389
AED BATTERY EXCHANGE, LLC
FR3-ABE
In Commercial Distribution

  • 00864312000277 ()


  • Disposable battery pack
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,, 9300E, 9390A, 9390E and Burdick Cardiovive AT (TM). Color White.
AED BATTERY EXCHANGE, LLC
9146-W-ABE
In Commercial Distribution

  • 00864312000253 ()


  • Primary battery
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT (TM). Color Yellow.
AED BATTERY EXCHANGE, LLC
9146-Y-ABE
In Commercial Distribution

  • 00864312000239 ()


  • Primary battery
Changing Rod, ø 2.9 mm
Karl Storz GmbH & Co. KG
26182TD
In Commercial Distribution

  • 04048551102268 ()
26182TD

  • Endoscope sheath exchange guide
Exchange transfusion set
VYGON
275.00
In Commercial Distribution

  • 53660812118489 ()
  • 13660812118481 ()
  • 03660812118484 ()
275.00

  • Blood transfusion set, exchange
Exchange transfusion set
VYGON
275.00
In Commercial Distribution

  • 53660812106127 ()
  • 13660812106129 ()
  • 03660812106122 ()
275.00

  • Blood transfusion set, exchange
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