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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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InHealth Technologies; Blom-Singer; Classic - 00813307011262

No Description
Freudenberg Medical, LLC
IN 2004-LEF
In Commercial Distribution

  • 00813307011262 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011248

No Description
Freudenberg Medical, LLC
IN 2020-NS
In Commercial Distribution

  • 00813307011248 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011231

No Description
Freudenberg Medical, LLC
IN 2018-NS
In Commercial Distribution

  • 00813307011231 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011125

No Description
Freudenberg Medical, LLC
IN 1616-NS
In Commercial Distribution

  • 00813307011125 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011118

No Description
Freudenberg Medical, LLC
IN 1614-NS
In Commercial Distribution

  • 00813307011118 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011101

No Description
Freudenberg Medical, LLC
IN 1612-NS
In Commercial Distribution

  • 00813307011101 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011095

No Description
Freudenberg Medical, LLC
IN 1610-NS
In Commercial Distribution

  • 00813307011095 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011088

No Description
Freudenberg Medical, LLC
IN 1608-NS
In Commercial Distribution

  • 00813307011088 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011071

No Description
Freudenberg Medical, LLC
IN 1606-NS
In Commercial Distribution

  • 00813307011071 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011064

No Description
Freudenberg Medical, LLC
IN 1604-NS
In Commercial Distribution

  • 00813307011064 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011057

No Description
Freudenberg Medical, LLC
IN 2014-SO
In Commercial Distribution

  • 00813307011057 ()


  • Tracheoesophageal speech valve, indwelling
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011040

No Description
Freudenberg Medical, LLC
IN 2012-SO
In Commercial Distribution

  • 00813307011040 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling

InHealth Technologies; Blom-Singer; Classic - 00813307011033

No Description
Freudenberg Medical, LLC
IN 2010-SO
In Commercial Distribution

  • 00813307011033 ()


  • Tracheoesophageal speech valve, indwelling
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011026

No Description
Freudenberg Medical, LLC
IN 2008-SO
In Commercial Distribution

  • 00813307011026 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling

InHealth Technologies; Blom-Singer; Classic - 00813307011019

No Description
Freudenberg Medical, LLC
IN 1614-SO
In Commercial Distribution

  • 00813307011019 ()


  • Tracheoesophageal speech valve, indwelling
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011002

No Description
Freudenberg Medical, LLC
IN 1612-SO
In Commercial Distribution

  • 00813307011002 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling

InHealth Technologies; Blom-Singer; Classic - 00813307011224

No Description
Freudenberg Medical, LLC
IN 2016-NS
In Commercial Distribution

  • 00813307011224 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011217

No Description
Freudenberg Medical, LLC
IN 2014-NS
In Commercial Distribution

  • 00813307011217 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011200

No Description
Freudenberg Medical, LLC
IN 2012-NS
In Commercial Distribution

  • 00813307011200 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011194

No Description
Freudenberg Medical, LLC
IN 2010-NS
In Commercial Distribution

  • 00813307011194 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011187

No Description
Freudenberg Medical, LLC
IN 2008-NS
In Commercial Distribution

  • 00813307011187 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011170

No Description
Freudenberg Medical, LLC
IN 2006-NS
In Commercial Distribution

  • 00813307011170 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307011163

No Description
Freudenberg Medical, LLC
IN 2004-NS
In Commercial Distribution

  • 00813307011163 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011149

No Description
Freudenberg Medical, LLC
IN 1620-NS
In Commercial Distribution

  • 00813307011149 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307011132

No Description
Freudenberg Medical, LLC
IN 1618-NS
In Commercial Distribution

  • 00813307011132 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307010999

No Description
Freudenberg Medical, LLC
IN 1610-SO
In Commercial Distribution

  • 00813307010999 ()


  • Tracheoesophageal speech valve, indwelling
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer

InHealth Technologies; Blom-Singer; Classic - 00813307010982

No Description
Freudenberg Medical, LLC
IN 1608-SO
In Commercial Distribution

  • 00813307010982 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling

Unimed - 06936735465095

'One-piece ECG Monitor Cable AAMI
Unimed Medical Supplies, Inc.
E10R-SH2-B/I-N
In Commercial Distribution

  • 06936735465095 ()


  • Electrocardiographic lead set, reusable

SHARPER IMAGE - 06936189900067

No Description
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
25 in
In Commercial Distribution

  • 06936189900067 ()


  • Hand-held electric massager

In Touch Lancing Device - 00853553005189

Black Lancing Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005189 ()
OFG00204

  • Manual blood lancing device, reusable

In Touch Glucose Control Solution - 00853553005158

In Touch Control solution with 1 bottle high, 1 bottle low
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005158 ()
OFG00155

  • Glucose IVD, control

In Touch Lancing Device - 00853553005141

Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005141 ()
OFG00156

  • Manual blood lancing device, reusable

In Touch Blood Glucose Test Strips - 00853553005110

Box of 1 Vial of 50 In Touch Test Strips
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005110 ()
OFG00154

  • Glucose IVD, reagent

In Touch Refill Kit - 00853553005103

6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005103 ()
KIT00147

  • Blood lancing device tip
  • Glucose IVD, control
  • Glucose IVD, reagent

In Touch Welcome Kit - 00853553005097

In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005097 ()
KIT00145

  • Glucose monitoring system IVD, home-use

In Touch Sterile Lancets - 00853553005066

Box of 100 Sterile Lancets
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005066 ()
OFG00142

  • Blood lancing device tip

Inb Touch Lancing Device - 00853553005059

Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005059 ()
OFG00141

  • Manual blood lancing device, reusable

In Touch Glucose Control Solutions - 00853553005028

Box of High/Low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005028 ()
OFG00140

  • Glucose IVD, control

Mad in Italy - 08056324149330

No Description
MAD IN ITALY SRL
CARDINALE5318140C04S
In Commercial Distribution

  • 08056324149330 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149323

No Description
MAD IN ITALY SRL
CARDINALE5318140C01S
In Commercial Distribution

  • 08056324149323 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149316

No Description
MAD IN ITALY SRL
PIETRO0005516145C04S
In Commercial Distribution

  • 08056324149316 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149309

No Description
MAD IN ITALY SRL
PIETRO0005516145C01S
In Commercial Distribution

  • 08056324149309 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149293

No Description
MAD IN ITALY SRL
LUCA000005518145C04S
In Commercial Distribution

  • 08056324149293 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149286

No Description
MAD IN ITALY SRL
LUCA000005518145C02S
In Commercial Distribution

  • 08056324149286 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149279

No Description
MAD IN ITALY SRL
PIPPO00005416145C04S
In Commercial Distribution

  • 08056324149279 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149262

No Description
MAD IN ITALY SRL
PIPPO00005416145C03S
In Commercial Distribution

  • 08056324149262 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149255

No Description
MAD IN ITALY SRL
LORENZO005022145C04S
In Commercial Distribution

  • 08056324149255 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149248

No Description
MAD IN ITALY SRL
LORENZO005022145C02S
In Commercial Distribution

  • 08056324149248 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149231

No Description
MAD IN ITALY SRL
ANTOLELLI5416140C04S
In Commercial Distribution

  • 08056324149231 ()


  • Tinted non-prescription spectacles

Mad in Italy - 08056324149224

No Description
MAD IN ITALY SRL
ANTOLELLI5416140C02S
In Commercial Distribution

  • 08056324149224 ()


  • Tinted non-prescription spectacles
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