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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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DreamStation CPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, INTL
In Commercial Distribution

  • 00606959025868 ()
INX400T15

  • Home CPAP unit
FitLife Mask with Headgear, with Standard Elbow, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959023093 ()
1061714

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Small, Japan
In Commercial Distribution

  • 00606959023086 ()
1061713

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Large, International
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, INTL
In Commercial Distribution

  • 00606959023062 ()
1061712

  • CPAP/BPAP face mask, reusable
DreamStation BiPAP Pro with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP Pro w/Humidifier, w/H Tube, US
In Commercial Distribution

  • 00606959022515 ()
DSX600T11

  • Home BPAP unit
DreamStation CPAP Pro with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/Heated Tube, US
In Commercial Distribution

  • 00606959022423 ()
DSX400T11

  • Home CPAP unit
REMstar SE with Heated Tube, with SD Slot, US
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, US
Not in Commercial Distribution

  • 00606959012509 ()
DS220TS

  • Home CPAP unit
  • Heated respiratory humidifier
DreamStation CPAP Pro with C Flex with Humidifier, GB
Respironics, Inc.
DreamStation CPAP Pro with C Flex with Humidifier, GB
In Commercial Distribution

  • 00606959043824 ()
GBX401H15

  • Home CPAP unit
Pouch with 100 electrodes (10 cards with 10 each)
Interacoustics A/S
TAB Electrode
In Commercial Distribution

  • 05711117129687 ()
  • 05711117199055 ()


  • Analytical non-scalp cutaneous electrode
Wheelchair Scale with Fold Seat, KG only with BT
Pelstar, LLC
2500CKG-BT
In Commercial Distribution

  • 00851628008363 ()


  • Wheelchair-accessible platform scale
VixOne Nebulizer with Pediatric Aerosol Mask (With Single Vents)
WESTMED, INC.
50311
In Commercial Distribution

  • 10709078001977 ()
  • 00709078001970 ()


  • Nebulizing system delivery set, single-use
VixOne Nebulizer with Adult Aerosol Mask (With Single Vents)
WESTMED, INC.
50310
Not in Commercial Distribution

  • 00709078001963 ()
  • 10709078001960 ()


  • Nebulizing system delivery set, single-use
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100040ATS
In Commercial Distribution

  • M665100040ATS3 ()
  • M665100040ATS1 ()
  • M665100040ATS0 ()

  • 40 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100036ATS
In Commercial Distribution

  • M665100036ATS3 ()
  • M665100036ATS1 ()
  • M665100036ATS0 ()

  • 36 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100032ATS
In Commercial Distribution

  • M665100032ATS3 ()
  • M665100032ATS1 ()
  • M665100032ATS0 ()

  • 32 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100028ATS
In Commercial Distribution

  • M665100028ATS3 ()
  • M665100028ATS1 ()
  • M665100028ATS0 ()

  • 28 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100024ATS
In Commercial Distribution

  • M665100024ATS3 ()
  • M665100024ATS1 ()
  • M665100024ATS0 ()

  • 24 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100020ATS
In Commercial Distribution

  • M665100020ATS3 ()
  • M665100020ATS1 ()
  • M665100020ATS0 ()

  • 20 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100016ATS
In Commercial Distribution

  • M665100016ATS3 ()
  • M665100016ATS1 ()
  • M665100016ATS0 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100014ATS
In Commercial Distribution

  • M665100014ATS3 ()
  • M665100014ATS1 ()
  • M665100014ATS0 ()

  • 14 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100012ATS
In Commercial Distribution

  • M665100012ATS3 ()
  • M665100012ATS1 ()
  • M665100012ATS0 ()

  • 12 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100010ATS
In Commercial Distribution

  • M665100010ATS3 ()
  • M665100010ATS1 ()
  • M665100010ATS0 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100008ATS
In Commercial Distribution

  • M665100008ATS3 ()
  • M665100008ATS1 ()
  • M665100008ATS0 ()

  • 8 FR


  • Pleural catheter
TiOS Scan Body with Screw Compatible with Biodenta B0
Biodenta Swiss AG
CAD-TSBBDBLB0S
In Commercial Distribution

  • 07640169736834 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Biodenta B2
Biodenta Swiss AG
CAD-TSBBDBLB2S
In Commercial Distribution

  • 07640169736407 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Biodenta B1
Biodenta Swiss AG
CAD-TSBBDBLB1S
In Commercial Distribution

  • 07640169736391 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Zimmer Screw-Vent 5.7
Biodenta Swiss AG
CAD-SBZTSV57
In Commercial Distribution

  • 07640169735578 ()
CAD-SBZTSV57

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Zimmer Screw-Vent 4.5
Biodenta Swiss AG
CAD-SBZTSV45
In Commercial Distribution

  • 07640169735561 ()
CAD-SBZTSV45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Zimmer Screw-Vent 3.5
Biodenta Swiss AG
CAD-SBZTSV35
In Commercial Distribution

  • 07640169735554 ()
CAD-SBZTSV35

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Nobel Active RP
Biodenta Swiss AG
CAD-SBNBARP
In Commercial Distribution

  • 07640169735523 ()
CAD-SBNBARP

  • Dental implant abutment analog, intraoral-scanning, single-use
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