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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THERMALATOR, 6 PACK, STATIONARY, 220V
Whitehall Manufacturing Co
T-6-S-220V_AMBER
In Commercial Distribution

  • 00645724004219 ()
T6S220VAMBER

  • Physical therapy paraffin wax bath
THERMOLATOR, 8 PACK, STATIONARY CRYO
Whitehall Manufacturing Co
T-8-S_CRYO
In Commercial Distribution

  • 00645724004202 ()
T8SCRYO

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V INDIA/S.A. CORD
Whitehall Manufacturing Co
PB-107B-CORD7
In Commercial Distribution

  • 00645724004196 ()
PB107BCORD7

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V RUSSIAN CORD
Whitehall Manufacturing Co
PB-107B-CORD6
In Commercial Distribution

  • 00645724004189 ()
PB107BCORD6

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V POWER CORD
Whitehall Manufacturing Co
PB-107B-CORD5
In Commercial Distribution

  • 00645724004172 ()
PB107BCORD5

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V ISRAEL CORD
Whitehall Manufacturing Co
PB-107B-CORD4
In Commercial Distribution

  • 00645724004165 ()
PB107BCORD4

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V AUSTRALIAN CORD
Whitehall Manufacturing Co
PB-107B-CORD3
In Commercial Distribution

  • 00645724004158 ()
PB107BCORD3

  • Physical therapy paraffin wax bath
PB107-PARAFFIN BATH 220V EUROPEAN CORD
Whitehall Manufacturing Co
PB-107B-CORD1
In Commercial Distribution

  • 00645724004134 ()
PB107BCORD1

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V INDIA/S.A. CORD
Whitehall Manufacturing Co
PB-105B-CORD7
In Commercial Distribution

  • 00645724004127 ()
PB105BCORD7

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V ISRAEL CORD
Whitehall Manufacturing Co
PB-105B-CORD4
In Commercial Distribution

  • 00645724004097 ()
PB105BCORD4

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V AUSTRALIAN CORD
Whitehall Manufacturing Co
PB-105B-CORD3
In Commercial Distribution

  • 00645724004080 ()
PB105BCORD3

  • Physical therapy paraffin wax bath
18 Lbs. Capacity All-Stainless Steel Paraffin Bath
Whitehall Manufacturing Co
PT-18-S
In Commercial Distribution

  • 00645724000105 ()
PT-18-S

  • Physical therapy paraffin wax bath
EXCHANGER 61399400964 12CA HT BIOTHERM
MEDTRONIC, INC.
61399400964
Not in Commercial Distribution

  • 00613994009647 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
EXCHANGER 61399400870 12CA EMOTRMII HT
MEDTRONIC, INC.
61399400870
Not in Commercial Distribution

  • 00613994008701 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
Optiflow Oxygen Kit
FISHER & PAYKEL HEALTHCARE LIMITED
AA451J
In Commercial Distribution

  • 09420012477927 ()
  • 09420012477910 ()
AA451J

  • Humidified oxygen administration set
No Description
Omm Imports Inc.
GZ100
In Commercial Distribution

  • 00850001456456 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/ir device for the treatment of wrinkles.
Omm Imports Inc.
J700B-B
In Commercial Distribution

  • 00850001456128 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR led device for the treatment of wrinkles.
Omm Imports Inc.
J700B-S
In Commercial Distribution

  • 00850001456111 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
PX100
In Commercial Distribution

  • 00850001456036 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P900B
In Commercial Distribution

  • 00850001456012 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P850B
In Commercial Distribution

  • 00850001456005 ()


  • Blue/red/infrared phototherapy lamp
ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
NEURODX DEVELOPMENT LLC
TP-1
In Commercial Distribution

  • 00865435000335 ()
  • 10865435000318 ()
TP-1

  • Heater/cooler system tester kit
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
Red LED light for the treatment of wrinkles
PULSADERM LLC
RB2010
In Commercial Distribution

  • 00864918000374 ()


  • Blue/red/infrared phototherapy lamp
No Description
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution

  • 00863626000201 ()


  • Cryopreserved blood/tissue thawing unit
No Description
Elixir M.D. Inc.
LED Light Therapy Device
In Commercial Distribution

  • 00860013019402 ()


  • Blue/red/infrared phototherapy lamp
LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
BIOPHOTAS, INC.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
5 Mode Light therapy device with capability of 3 Panels connected
BIOPHOTAS, INC.
Series 2 ELITE C/US
In Commercial Distribution

  • 00850523007761 ()
ELS2-002

  • Blue/red/infrared phototherapy lamp
2 mode small panel
BIOPHOTAS, INC.
Series 2 FACE C/US
In Commercial Distribution

  • 00850523007754 ()
CLF2-001

  • Blue/red/infrared phototherapy lamp
2 mode small panel light therapy device
BIOPHOTAS, INC.
Series 2 HOME C/US
In Commercial Distribution

  • 00850523007747 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
3 mode small panel light therapy device
BIOPHOTAS, INC.
Series 2 RESTORE C/US
In Commercial Distribution

  • 00850523007730 ()
CLR2-001

  • Blue/red/infrared phototherapy lamp
4 mode small panel light therapy device
BIOPHOTAS, INC.
Series 2 LITE C/US
In Commercial Distribution

  • 00850523007723 ()
CML2-001

  • Blue/red/infrared phototherapy lamp
3 mode large panel light therapy device
BIOPHOTAS, INC.
Series 2 PRO C/US
In Commercial Distribution

  • 00850523007716 ()
CLP2-001

  • Blue/red/infrared phototherapy lamp
4 mode large panel light therapy device
BIOPHOTAS, INC.
Series 2 PRO PLUS C/US
In Commercial Distribution

  • 00850523007709 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
1 mode large panel
BIOPHOTAS, INC.
Series 2 SPORT C/US
In Commercial Distribution

  • 00850523007648 ()
CSP2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
BIOPHOTAS, INC.
SKIN C/US
In Commercial Distribution

  • 00850523007600 ()
CSKN-001

  • Blue/red/infrared phototherapy lamp
4 Mode Light therapy device with capability of 3 Panels connected
BIOPHOTAS, INC.
Series 2 CONTOUR C/US
In Commercial Distribution

  • 00850523007594 ()
CTG2-001

  • Blue/red/infrared phototherapy lamp
Hand held device 3-mode
BIOPHOTAS, INC.
POD C/US
In Commercial Distribution

  • 00850523007501 ()
CPOD-001

  • Blue/red/infrared phototherapy lamp
No Description
BIOPHOTAS, INC.
Home
In Commercial Distribution

  • 00850523007402 ()
  • 00850523007419 ()


  • Blue/red/infrared phototherapy lamp
No Description
BIOPHOTAS, INC.
Elite C/US
In Commercial Distribution

  • 00850523007303 ()


  • Blue/red/infrared phototherapy lamp
No Description
BIOPHOTAS, INC.
Lite C/US
In Commercial Distribution

  • 00850523007204 ()


  • Blue/red/infrared phototherapy lamp
3 mode small panel
BIOPHOTAS, INC.
iLITE C/US
In Commercial Distribution

  • 00850523007181 ()
CLTB-001

  • Blue/red/infrared phototherapy lamp
3 mode large panel
BIOPHOTAS, INC.
iPRO C/US
In Commercial Distribution

  • 00850523007174 ()
COTB-001

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
BIOPHOTAS, INC.
DELUX XL C/US
In Commercial Distribution

  • 00850523007143 ()
CDLX-003

  • Blue/red/infrared phototherapy lamp
3 mode device. Hair, Wrinkles, Aches & Pains
BIOPHOTAS, INC.
RESTORE C/US
In Commercial Distribution

  • 00850523007136 ()
CLRS-001

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
BIOPHOTAS, INC.
DELUX C/US
In Commercial Distribution

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
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