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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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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

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

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 - 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 - 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

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

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

Airo™ CPAP Mask Liners - 30850054813313

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
EVAL-AS-100
In Commercial Distribution

  • 00850054813312 ()
  • 30850054813313 ()
EVAL-AS-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813306

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
EVAL-AM-100
In Commercial Distribution

  • 00850054813305 ()
  • 30850054813306 ()
EVAL-AM-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813283

Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
SMPL-AL-25
In Commercial Distribution

  • 00850054813282 ()
  • 30850054813283 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813245

Sample - Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
SMPL-AM-25
In Commercial Distribution

  • 00850054813244 ()
  • 30850054813245 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813207

Sample - Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
SMPL-AS-25
In Commercial Distribution

  • 00850054813206 ()
  • 30850054813207 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813115

Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
SMPL-AL-25
Not in Commercial Distribution

  • 00850054813114 ()
  • 30850054813115 ()
SMPL-AL-25

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813108

Sample - Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
SMPL-AM-25
Not in Commercial Distribution

  • 00850054813107 ()
  • 30850054813108 ()
SMPL-AM-25

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813092

Sample - Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
SMPL-AS-25
Not in Commercial Distribution

  • 00850054813091 ()
  • 30850054813092 ()
SMPL-AS-25

  • General-purpose medical fibre padding

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

K&FCOPTEE - 06977160620031

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

  • 06977160620031 ()


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