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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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Diamondback Coronary - 10852528005138

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005138 ()
70057-03

  • Atherectomy system saline/lubricant pump

Viperslide - 10852528005121

VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant

ViperTrack - 10852528005114

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPRTRKMM20
In Commercial Distribution

  • 30852528005118 ()
  • 10852528005114 ()

  • Length: 500 Millimeter
72029-01

  • X-ray film ruler

ViperTrack - 10852528005107

VIPERTRACK, 50 PACK
Cardiovascular Systems, Inc.
VPR-TRK
In Commercial Distribution

  • 30852528005101 ()
  • 10852528005107 ()

  • Length: 30 Centimeter
72014-02

  • X-ray film ruler

ViperTrack - 10852528005091

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPR-TRK 20
In Commercial Distribution

  • 10852528005091 ()
  • 30852528005095 ()

  • Length: 30 Centimeter
72014-01

  • X-ray film ruler

ViperWire, Advance - 10852528005084

VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-17
In Commercial Distribution

  • 30852528005088 ()
  • 10852528005084 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.017 inches
72023-02

  • Peripheral vascular guidewire, manual

ViperWire, Advance - 10852528005077

VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-14
In Commercial Distribution

  • 30852528005071 ()
  • 10852528005077 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
72023-01

  • Peripheral vascular guidewire, manual

Stealth - 10852528005060

STEALTH, SOLID MICRO, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125S
In Commercial Distribution

  • 10852528005060 ()

  • Crown Type, Solid Micro
  • Intro Sheath 6Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown Diameter 1.25 mm
70056-11

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005053

STEALTH, SOLID, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10852528005053 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Solid
70056-06

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005046

STEALTH, SOLID, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10852528005046 ()

  • Intro Sheath 6 Fr
  • max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown diameter 1.50 mm
  • Crown Type, Solid
70056-04

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005039

STEALTH, SOLID, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10852528005039 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
70056-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005022

STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005015

STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 15 mm
  • Crown diameter 1.50 mm
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral

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 - 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 - 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

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

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

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 - 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 - 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 - 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 - 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

G5 - 00746980000356

The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.
GENERAL PHYSIOTHERAPY INC
FF24B
In Commercial Distribution

  • 00746980000356 ()

  • Weight: 12 Pound
FF24B

  • Hand-held electric massager

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

G5® - 00746980000783

The G5 Neocussor is a gentle, quiet, Directional-Stroking® model designed specifically for neonatal applications. The lungs of a neonate frequently cannot perform the cough mechanism due to their premature condition. The G5 Neocussor provides a soothing, precise treatment to help loosen, and help mobilize secretion build-up in neonates. It is small enough to fit inside infant environmental chambers; is powered by a single "C" cell replaceable battery, and weighs less than five ounces. Comes with two (2) Directional-Stroking disposable applicators and one vibration applicator. Unit Advantages: Soft rubber end cushions unit in the event of a fall. Red Arrow indicates the direction of fluid movement. Comes with three different applicators.
GENERAL PHYSIOTHERAPY INC
NC90
Not in Commercial Distribution

  • 00746980000783 ()

  • Weight: 3 Pound
NC90

  • Neonatal chest percussor

G5® - 00746980000776

The G5 Neocussor is a gentle, quiet, Directional-Stroking® model designed specifically for neonatal applications. The lungs of a neonate frequently cannot perform the cough mechanism due to their premature condition. The G5 Neocussor provides a soothing, precise treatment to help loosen, and help mobilize secretion build-up in neonates. It is small enough to fit inside infant environmental chambers; is powered by a single "C" cell replaceable battery, and weighs less than five ounces. Comes with two (2) Directional-Stroking disposable applicators and one vibration applicator. Unit Advantages: Soft rubber end cushions unit in the event of a fall. Red Arrow indicates the direction of fluid movement. Comes with three different applicators.
GENERAL PHYSIOTHERAPY INC
NC90
Not in Commercial Distribution

  • 00746980000776 ()

  • Weight: 3 Pound
NC90

  • Neonatal chest percussor
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