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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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AF811 - 00606959034365

AF811 Mask with Headgear, Small
Respironics, Inc.
AF811 Mask with Headgear, Small, Single Use
In Commercial Distribution

  • 30606959034366 ()
  • 00606959034365 ()
1120253

  • CPAP/BPAP face mask, single-use

AF811 - 00606959034358

AF811 Mask with Headgear, Medium
Respironics, Inc.
AF811 Mask with Headgear, Medium, Single Use
In Commercial Distribution

  • 30606959034359 ()
  • 00606959034358 ()
1120252

  • CPAP/BPAP face mask, single-use

AF811 - 00606959034341

AF811 Mask with Headgear, Large
Respironics, Inc.
AF811 Mask with Headgear, Large, Single Use
In Commercial Distribution

  • 30606959034342 ()
  • 00606959034341 ()
1120251

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959034044

DreamStation CPAP with WiFi, USA
Respironics, Inc.
DreamStation CPAP w/WiFi, US
In Commercial Distribution

  • 00606959034044 ()
DSX200S11W

  • Home CPAP unit

EverFlo - 00606959032538

EverFlo with OPI, 220V - Brazil
Respironics, Inc.
EVERFLO w/O2 Percentage Indicator, 220V, LA, BR
Not in Commercial Distribution

  • 00606959032538 ()
1020004

  • Stationary oxygen concentrator

EverFlo - 00606959032514

EverFlo with OPI, 120V, L.A.
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 120V, L.A
In Commercial Distribution

  • 00606959032514 ()
1020002

  • Stationary oxygen concentrator

Dorma - 00606959007413

Dorma 200 with Humidifier, USA
Respironics, Inc.
Dorma 200, with Humidifier, US
In Commercial Distribution

  • 00606959007413 ()
DSV200H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma - 00606959006942

Dorma 100 with Humidifier, LA
Respironics, Inc.
Dorma 100 with Humidifier, LA
In Commercial Distribution

  • 00606959006942 ()
LAV101H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma - 00606959006928

Dorma 100 with Humidifier, International
Respironics, Inc.
Dorma 100 with Humidifier, INTL
In Commercial Distribution

  • 00606959006928 ()
INV101H

  • Heated respiratory humidifier
  • Home CPAP unit

Performatrak - 00606959003286

PERFORMATRAK FULL with CAPSTRAP, MEDIUM
Respironics, Inc.
PERFORMATRAK FULL w CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959003287 ()
  • 00606959003286 ()
1041445

  • CPAP/BPAP face mask, single-use
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