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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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SmartVest - B102070124S3440

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

  • B102070124S3440 ()
SV2100-HKG

  • Chest-oscillation airway secretion-clearing system vest

Venclose System Power Cord - 00858254006060

Power Cord, UK, Hong Kong
VENCLOSE INC
VCPCG
In Commercial Distribution

  • 00858254006060 ()


  • Electrical mains power cable

NEUWAVE - 00818913020073

NW Flex System, Hong Kong
NEUWAVE MEDICAL, INC.
NWF2HK1N
Not in Commercial Distribution

  • 00818913020073 ()
NWF2HK1N

  • Microwave ablation system generator

SmartVest - B102090649S0800

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 - 00606959032644

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 - 00606959050181

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-PLO2R - 00850029991304

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

  • 00850029991304 ()


  • Mobile/portable oxygen concentrator

Integra® Padgett® Dermatomes - 10381780277378

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 Standard - 10845357042047

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

PolyLock Ankle - 00840124520967

King Kong Clamp
FUSION ORTHOPEDICS, LLC
TN-AK-0005
In Commercial Distribution

  • 00840124520967 ()
TN-AK-0005

  • Bone approximation clamp
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