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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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Qube - 10841522131455

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Compact Monitor
In Commercial Distribution

  • 10841522131455 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

OptiMap™ System - NA - 00850064686135

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Cortex, Inc.
FG0001-NA
In Commercial Distribution

  • 00850064686135 ()
OPTI-SYS-NA

  • Cardiac mapping system

OptiMap Monitor - 00850064686029

OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system

OptiMap™ Workstation - 00850064686012

OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094230871

CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230826

CIWS WRLS NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230826 ()
  • 00732094055054 ()
85NXVE

  • Multiple vital physiological parameter monitoring system, clinical

E2 EasySet Removable Mounting Hardware (fits 1-1/8" canes) - 07540147001230

E2 EasySet Mounting Hardware (pair) designed to install onto 1-1/8" back canes (includes E2 EasySet Mounting Pin Interface Brackets). Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release (removable) design.
Motion Concepts Inc
E2PBMH-Q
In Commercial Distribution

  • 07540147001230 ()
E2PBMH-Q

  • Wheelchair back rest positioner

E2 EasySet Removable Mounting Hardware (fits 1-1/4" canes) - 07540147001247

E2 EasySet Mounting Hardware (pair) designed to install onto 1-1/4" back canes (includes E2 EasySet Mounting Pin Interface Brackets). Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release (removable) design.
Motion Concepts Inc
E2PBMH-X
In Commercial Distribution

  • 07540147001247 ()
E2PBMH-X

  • Wheelchair back rest positioner

PMT® CORPORATION HALO - 00650551044840

HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
PMT CORPORATION
1201-36
In Commercial Distribution

  • 00650551044840 ()
1201-36

  • Cervical spine immobilization system, single-use

Axiom - 00840363368436

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368436 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4X5PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368429

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368429 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLS3X4PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368375

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368375 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4X5PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368368

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368368 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3X4PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368313

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368313 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4X5PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368306

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368306 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLS3X4PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369037

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369037 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369020

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369020 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLASC3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369013

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369013 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369006

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369006 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368931

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368931 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368924

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368924 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLASC3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368917

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368917 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368900

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368900 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368832

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368832 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLASC4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368825

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368825 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLASC3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368818

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368818 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368801

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368801 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLAS3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368733

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368733 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLASC4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368726

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368726 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLASC3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368719

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368719 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368702

3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368702 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLAS3x4BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368610

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368610 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4X5PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368603

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368603 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLS3X4PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368559

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368559 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4X5PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368542

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368542 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLS3X4PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368498

4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368498 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLS4X5PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368481

3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368481 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLS3X4PBP

  • Wheelchair head/trunk support, prefabricated

Matrx-Vi Drop Base (Cushion) - 07540147000776

Matrx-Vi Drop Base. (Standard Skin Protection & Positioning Cushion). Includes hardware. Weight capacity up to 300lb.
Motion Concepts Inc
MB-Vi
In Commercial Distribution

  • 07540147000776 ()
MBwwdd-Vi

  • Foam-filled chair cushion

StrokeSENS LVO - 00882916001025

StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software

TruPlan - 00882916000530

No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution

  • 00882916000530 ()


  • CT system application software

TruPlan - 00882916000523

No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution

  • 00882916000523 ()


  • CT system application software

TruPlan - 00882916000516

No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution

  • 00882916000516 ()
v1.x and v2.0

  • CT system application software

mfiVerse - 00860059002109

No Description
MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution

  • 00860059002109 ()


  • PET system application software

SOTA Cloud Imaging - 00860013687632

Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution

  • 00860013687632 ()


  • General-purpose dental x-ray system application software

MC2 Portable X-ray System - 00860008892782

No Description
OXOS Medical, Inc.
MC2
In Commercial Distribution

  • 00860008892782 ()


  • Hand-held basic diagnostic x-ray system, digital

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

Cart - 00860008892737

No Description
OXOS Medical, Inc.
K1
In Commercial Distribution

  • 00860008892737 ()


  • Hand-held basic diagnostic x-ray system, digital

Wired Charger - 00860008892713

No Description
OXOS Medical, Inc.
H1
In Commercial Distribution

  • 00860008892713 ()


  • Hand-held basic diagnostic x-ray system, digital

Foot Pedal - 00860008892706

No Description
OXOS Medical, Inc.
F1
In Commercial Distribution

  • 00860008892706 ()


  • Hand-held basic diagnostic x-ray system, digital

Varian Acuity with Conebeam Computed Tomography - 00856545006010

No Description
VARIAN MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00856545006010 ()
TM64001000

  • Radiation therapy simulation system
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