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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Caregiver Key
Smart Caregiver Corporation
CK-01
In Commercial Distribution

  • 00812293010280 ()


  • Patient monitor remote control
No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
5100047
In Commercial Distribution

  • 04255629200515 ()
5100047

  • Patient monitor remote control
No Description
GE Healthcare Finland Oy
USB Remote Control
In Commercial Distribution

  • 00840682104449 ()


  • Patient monitor remote control
Personal Alarm
Dynarex Corporation
7082
In Commercial Distribution

  • 00616784708232 ()
  • 00616784708225 ()


  • Patient monitor remote control
No Description
FUKUDA DENSHI CO.,LTD.
CF-820
In Commercial Distribution

  • 04538612909221 ()


  • Patient monitor remote control
Remote Control
Philips Medizin Systeme Bƶblingen GmbH
865244
In Commercial Distribution

  • 00884838020740 ()
865244

  • Patient monitor remote control
Remote Event Marker
Philips Medizin Systeme Bƶblingen GmbH
Remote Event Marker
In Commercial Distribution

  • 00884838009950 ()
989803143411

  • Patient monitor remote control
Home From the Hospital Kit
DOREL JUVENILE GROUP, INC.
IH576
In Commercial Distribution

  • 20884392950495 ()


  • Oral medicine dropper
  • Intermittent electronic patient thermometer
  • Skin cleaning wipe
  • Nasal aspirator, manual
Home From the Hospital Kit
DOREL JUVENILE GROUP, INC.
IH575
In Commercial Distribution

  • 10884392950498 ()


  • Oral medicine dropper
  • Intermittent electronic patient thermometer
  • Skin cleaning wipe
  • Nasal aspirator, manual
Home From the Hospital Kit
DOREL JUVENILE GROUP, INC.
IH574
In Commercial Distribution

  • 00884392950491 ()


  • Oral medicine dropper
  • Intermittent electronic patient thermometer
  • Skin cleaning wipe
  • Nasal aspirator, manual
ivWatch Patient Monitor, Model 400, English, Lease
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020382 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020382

  • Intravenous access site infiltration/extravasation monitoring system monitor
A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020092 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020092

  • Intravenous access site infiltration/extravasation monitoring system monitor
A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
IVWATCH, LLC
Model 400
In Commercial Distribution

  • 00814088020009 ()

  • Weight: 2.5 Pound
  • Depth: 2.63 Inch
  • Width: 6.14 Inch
  • Length: 8.0 Inch
00814088020009

  • Intravenous access site infiltration/extravasation monitoring system monitor
Infant Skin Temperature Probe, Single Patient Use (Giraffeā„¢, Pandaā„¢)
AIRLIFE
2074816-001
In Commercial Distribution

  • 20190752106144 ()
  • 10190752106147 ()
2074816-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use (Giraffeā„¢, Pandaā„¢)
AIRLIFE
2074817-001
In Commercial Distribution

  • 20190752106137 ()
  • 10190752106130 ()
  • 50190752106138 ()
2074817-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use, (Giraffeā„¢, Pandaā„¢)
Carefusion Finland 320 Oy
2074817-001
Not in Commercial Distribution

  • 20885403253697 ()
  • 70885403253692 ()
  • 10885403253690 ()
2074817-001

  • General-purpose patient temperature probe, single-use
Infant Skin Temperature Probe, Single Patient Use, (Giraffeā„¢, Pandaā„¢)
Carefusion Finland 320 Oy
2074816-001
Not in Commercial Distribution

  • 20885403253680 ()
  • 10885403253683 ()
2074816-001

  • General-purpose patient temperature probe, single-use
No Description
OTOHARMONICS CORPORATION
PATIENT
In Commercial Distribution

  • B400215930 ()


  • Tinnitus masking application software
No Description
Levo Medical Corporation
Patient
In Commercial Distribution

60452

  • Tinnitus masking application software
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN045545
In Commercial Distribution

  • 24026704391831 ()
  • 04026704391837 ()
  • 14026704391834 ()

  • Patient
8884719041

  • Incentive spirometer
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN045544
In Commercial Distribution

  • 24026704391824 ()
  • 04026704391820 ()
  • 14026704391827 ()

  • Patient
8884719033

  • Incentive spirometer
VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness
TELEFLEX INCORPORATED
IPN045543
In Commercial Distribution

  • 24026704597011 ()
  • 04026704597017 ()
  • 14026704597014 ()

  • Patient
8884719025

  • Incentive spirometer
PEDIATRIC VOLDYNE VOLUMETRIC EXERCISER
TELEFLEX INCORPORATED
IPN045542
In Commercial Distribution

  • 24026704597004 ()
  • 04026704597000 ()
  • 14026704597007 ()

  • Patient
8884719017

  • Incentive spirometer
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN045541
In Commercial Distribution

  • 24026704596991 ()
  • 04026704596997 ()
  • 14026704596994 ()

  • Patient
8884719009

  • Incentive spirometer
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN049320
In Commercial Distribution

  • 34026704630210 ()
  • 14026704630216 ()

  • Patient
8884719041

  • Incentive spirometer
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN049319
In Commercial Distribution

  • 34026704630203 ()
  • 14026704630209 ()

  • Patient
8884719033

  • Incentive spirometer
VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness
TELEFLEX INCORPORATED
IPN049318
In Commercial Distribution

  • 34026704630197 ()
  • 14026704630193 ()
  • 04026704597017 ()

  • Patient
8884719025

  • Incentive spirometer
PEDIATRIC VOLDYNE VOLUMETRIC EXERCISER
TELEFLEX INCORPORATED
IPN049317
In Commercial Distribution

  • 34026704630180 ()
  • 14026704630186 ()
  • 04026704597000 ()

  • Patient
8884719017

  • Incentive spirometer
Volumetric Exerciser
TELEFLEX INCORPORATED
IPN049316
In Commercial Distribution

  • 34026704630173 ()
  • 14026704630179 ()
  • 04026704596997 ()

  • Patient
8884719009

  • Incentive spirometer
No Description
HELENA LABORATORIES CORPORATION
5757000
In Commercial Distribution

  • M52557570000 ()


  • Coagulation analyser IVD, laboratory
Red and Infrared heating wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-ZLD-60-NW
In Commercial Distribution

  • 00810025926977 ()


  • Red/infrared light phototherapy unit
Red and infrared heating wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-ZLD-60-BP
In Commercial Distribution

  • 00810025926960 ()


  • Red/infrared light phototherapy unit
Red and Infrared heating wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-ZLD-60
In Commercial Distribution

  • 00810025926953 ()


  • Red/infrared light phototherapy unit
64 LED Infrared Phototherapy Pad
HEALTHLIGHT LLC
HL-64R
In Commercial Distribution

  • 00858935006259 ()
502031

  • Musculoskeletal infrared phototherapy unit, non-wearable
64 LED Infrared Phototherapy System
HEALTHLIGHT LLC
HL-64-S
In Commercial Distribution

  • 00858935006242 ()
502030

  • Musculoskeletal infrared phototherapy unit, non-wearable
Boot Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-BV
In Commercial Distribution

  • 00858935006075 ()
502007

  • Musculoskeletal infrared phototherapy unit, non-wearable
Face Mask, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-FM
In Commercial Distribution

  • 00858935006051 ()
502005

  • Musculoskeletal infrared phototherapy unit, non-wearable
Infrared lamp for therapeutic healing
ACCELERATED CARE PLUS CORP
76896
In Commercial Distribution

  • 00858703006061 ()
  • 10858703006068 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
PILLOW SPEAKER,ELITE INFRARED, ETKACOM
Crest Healthcare Supply
XN15CCEIXXXXTAAYL
In Commercial Distribution

  • B484XN15CCEIXXXXTAAYL0 ()

  • Length: 6 Inch


  • Nurse call system
PILLOW SPEAKER,ELITE INFRARED, ETKACOM
Crest Healthcare Supply
EN15CCEEIIXXXXTAL
In Commercial Distribution

  • B484EN15CCEEIIXXXXTAL0 ()

  • Length: 6 Inch


  • Nurse call system
Infrared & Red light therapy wrap
FKA DISTRIBUTING CO., LLC
IFR-100HJ
In Commercial Distribution

  • 00031262110381 ()


  • Red/infrared light phototherapy unit
red/infrared light phototherapy unit
Ochs Labs LLC
1
In Commercial Distribution

  • G253R30 ()


  • Red/infrared light phototherapy unit
Contact Tip/Sheath
Coopersurgical, Inc.
RIRC-DT6210
In Commercial Distribution

  • 20888937013256 ()
  • 00888937013252 ()

  • Length: 210 Millimeter
  • Outer Diameter: 6 Millimeter


  • Infrared tissue coagulation system handpiece
Contact Tip/Sheath
Coopersurgical, Inc.
RIRC-DT6120
In Commercial Distribution

  • 20888937013249 ()
  • 00888937013245 ()

  • Length: 120 Millimeter
  • Outer Diameter: 6 Millimeter


  • Infrared tissue coagulation system handpiece
Disposable Thermometer Adaptor
TELEFLEX INCORPORATED
IPN042680
In Commercial Distribution

  • 14026704595027 ()
  • 34026704595021 ()
1645

  • Straight/elbow breathing circuit connector, single-use
DISPOSABLE THERMOMETER,INTL
TELEFLEX INCORPORATED
IPN044433
In Commercial Distribution

  • 14026704390141 ()
  • 34026704390145 ()
41635

  • Respiratory gas thermometer
Multi-Use Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A7
In Commercial Distribution

  • B268Y7078A71 ()
  • B268Y7078A70 ()
  • B268Y7078A74 ()
  • B268Y7078A76 ()
Y7078A7

  • General-purpose patient temperature probe, reusable
Digital oral Thermometer
FUTURE DIAGNOSTICS LLC
ET-110
In Commercial Distribution

  • 20370393421015 ()
  • 00370393421011 ()


  • General-purpose patient temperature probe, reusable
DISPOSABLE THERMOMETER,INTL
TELEFLEX INCORPORATED
IPN044433
In Commercial Distribution

  • 24026704390148 ()
  • 04026704390144 ()
41635

  • Respiratory gas thermometer
Disposable Thermometer Adaptor
TELEFLEX INCORPORATED
IPN042680
In Commercial Distribution

  • 24026704595024 ()
  • 04026704595020 ()
1645

  • Straight/elbow breathing circuit connector, single-use
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