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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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Airo™ CPAP Mask Liners - 10850054813241

Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
In Commercial Distribution

  • 00850054813244 ()
  • 10850054813241 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 10850054813203

Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
In Commercial Distribution

  • 00850054813206 ()
  • 10850054813203 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 10850054813111

Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
Not in Commercial Distribution

  • 00850054813114 ()
  • 10850054813111 ()
SMPL-AL-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 10850054813104

Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
Not in Commercial Distribution

  • 00850054813107 ()
  • 10850054813104 ()
SMPL-AM-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 10850054813098

Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
Not in Commercial Distribution

  • 00850054813091 ()
  • 10850054813098 ()
SMPL-AS-100

  • General-purpose medical fibre padding

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005107

Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005022

Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005008

Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system

Flotec - B741RW0

No Description
FLOTEC INC
RW Regulator
In Commercial Distribution

  • B741RW0 ()


  • Non-fixed medical gas cylinder regulator

Flotec - B741MC0

No Description
FLOTEC INC
Mass Casualty Assembly
In Commercial Distribution

  • B741MC0 ()


  • High-pressure medical gas hose
  • Medical gas flowmeter, dial-type
  • Non-fixed medical gas cylinder regulator

Flotec - B741FM0

No Description
FLOTEC INC
Flowmeter
In Commercial Distribution

  • B741FM0 ()


  • Medical gas flowmeter, dial-type

Flotec - B741DL0

No Description
FLOTEC INC
InGage Regulator
In Commercial Distribution

  • B741DL0 ()


  • Non-fixed medical gas cylinder regulator

G5® - 00007469820231

The G5 Vibracare ZX1 Percussor is our durable, hand-held percussor used in respiratory therapy applications. Totally self-contained, and weighing less than three pounds, it provides optimal freedom of movement and portability with a ten foot hospital grade power cord. This model may be used with a variety of applicators and has a continuously-variable speed range of 20 - 50 cycles per second. This combination of applicators and speeds provides for a highly-versatile treatment range. It is the only hand-held percussor/massager to be granted C.S.A's highest medical operational rating. Comes with applicators 212, 216, 229, 230.
GENERAL PHYSIOTHERAPY INC
VIBRACARE ZX1
In Commercial Distribution

  • 00007469820231 ()

  • Weight: 6 Pound
VIBRACARE ZX1

  • Hand-held electric massager

Dr.MUSIC - 00193026000007

No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

SCOOP - B181C920

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9-2
In Commercial Distribution

  • B181C920 ()
C-9-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C11HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11HF-2
In Commercial Distribution

  • B181C11HF20 ()
C-11HF-2

  • Oxygen administration transtracheal catheter

Fifty50 Sport - 00892896000260

Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000093

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent

Fifty50 - 00892896000086

Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000017

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent

SCOOP - B181C9HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9HF-2
In Commercial Distribution

  • B181C9HF20 ()
C-9HF-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C90

Transtracheal Catheter and Cleaning Rod (Single Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9
In Commercial Distribution

  • B181C90 ()
C-9

  • Oxygen administration transtracheal catheter

SCOOP - B181C1120

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11-2
In Commercial Distribution

  • B181C1120 ()
C-11-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C110

Transtracheal Catheter and Cleaning Rod (Single Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11
In Commercial Distribution

  • B181C110 ()
C-11

  • Oxygen administration transtracheal catheter

Freezpen® - B386CLN2O8GUNBOX1

No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GUNCARTON2 ()
  • B386CLN2O8GUNBOX1 ()
  • B386CLN2O8GUNBOX0 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen - B386CLN2O8GBOX1

No Description
H & O Equipments SA
8g N2O cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GCARTON2 ()
  • B386CLN2O8GBOX1 ()
  • B386CLN2O8GBOX0 ()
CL-N2O-8G-BOX

  • Nitrous oxide gas cartridge

Freezpen® - B386CLN2O16GUNBOX1

No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O16GUNCARTON2 ()
  • B386CLN2O16GUNBOX1 ()
  • B386CLN2O16GUNBOX0 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - B386CLFPU180

No Description
H & O Equipments SA
Freezpen 16G
In Commercial Distribution

  • B386CLFPU180 ()
CL-FPU-18

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFPU020

No Description
H & O Equipments SA
Freezpen 8G
In Commercial Distribution

  • B386CLFPU020 ()
CL-FPU-02

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFP160

No Description
H & O Equipments SA
Freezpen 16G
In Commercial Distribution

  • B386CLFP160 ()
CL-FP-16

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFP010

No Description
H & O Equipments SA
Freezpen 8G
In Commercial Distribution

  • B386CLFP010 ()
CL-FP-01

  • Nitrous oxide gas cartridge

Freezpen - B386CLFP000

No Description
H & O Equipments SA
Freezpen
In Commercial Distribution

  • B386CLFP000 ()
CL-FP-00

  • General cryosurgical system, cryogen gas, mechanical

Medical Reverse Osmosis - B297KROUPT5600

UPT-560 Medical RO - 6 Membrane - 10 gpm Permeate Production
SPECIALITY WATER TECHNOLOGY
K-RO-UPT-560
In Commercial Distribution

  • B297KROUPT5600 ()


  • Reverse-osmosis water purification system

Airo™ CPAP Mask Liners - 20850054813309

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
EVAL-AM-50
In Commercial Distribution

  • 00850054813305 ()
  • 20850054813309 ()
EVAL-AM-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813248

Sample - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
SMPL-AM-50
In Commercial Distribution

  • 00850054813244 ()
  • 20850054813248 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813118

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
Not in Commercial Distribution

  • 00850054813114 ()
  • 20850054813118 ()
SMPL-AL-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813286

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
In Commercial Distribution

  • 00850054813282 ()
  • 20850054813286 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813200

Sample - Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
SMPL-AS-50
In Commercial Distribution

  • 00850054813206 ()
  • 20850054813200 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813101

Sample - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
SMPL-AM-50
Not in Commercial Distribution

  • 00850054813107 ()
  • 20850054813101 ()
SMPL-AM-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813095

Sample - Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
SMPL-AS-50
Not in Commercial Distribution

  • 00850054813091 ()
  • 20850054813095 ()
SMPL-AS-50

  • General-purpose medical fibre padding

K&FCOPTEE - 06977160620031

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M908
In Commercial Distribution

  • 06977160620031 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620024

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M802
In Commercial Distribution

  • 06977160620024 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620017

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M606
In Commercial Distribution

  • 06977160620017 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620055

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M607
In Commercial Distribution

  • 06977160620055 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620048

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M609
In Commercial Distribution

  • 06977160620048 ()


  • Air-conduction hearing aid, in-the-ear

WHEELCHAIR - 06977027830610

No Description
Zhejiang Nysin Medical Co.,Ltd
XFGW25-203
In Commercial Distribution

  • 06977027830610 ()


  • Electric-motor-driven wheelchair, occupant-controlled

Breathe Pure - 00810021178363

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178377 ()
  • 00810021178363 ()
  • 20810021178428 ()
  • 30810021178050 ()


  • Infrared patient thermometer, skin

KKmier - 00810021178219

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178216 ()
  • 00810021178219 ()
  • 20810021178220 ()


  • Infrared patient thermometer, skin

WISHDREAM - 00810021178158

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178155 ()
  • 00810021178158 ()
  • 20810021178169 ()


  • Infrared patient thermometer, skin

konjac - 00810021178134

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178131 ()
  • 00810021178134 ()


  • Infrared patient thermometer, skin
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