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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TiOS Scan Body with Screw Compatible with Nobel Replace WP
Biodenta Swiss AG
CAD-TSBNRWPS
In Commercial Distribution

  • 07640169736643 ()


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

  • 07640169736636 ()


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

  • 07640169736629 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Straumann Bone Level RC
Biodenta Swiss AG
CAD-SBSBLRC
In Commercial Distribution

  • 07640169735592 ()
CAD-SBSBLRC

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Straumann Bone Level NC
Biodenta Swiss AG
CAD-SBSBLNC
In Commercial Distribution

  • 07640169735585 ()
CAD-SBSBLNC

  • Dental implant abutment analog, intraoral-scanning, single-use
AF811 Mask with Standard Elbow, with Headgear, Single Use, Medium
Respironics, Inc.
AF811 Mask w/SE, with Headgear, Medium, Single Use
In Commercial Distribution

  • 00606959007673 ()
1063049

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal, Medium with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Medium, Med Connector w/Headgear, APr, AP
In Commercial Distribution

  • 00606959057258 ()
1137944AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Mask, Large with Small/Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, L, Sm/Med Connector, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054486 ()
1139335

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, L, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051188 ()
1137950

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Medium with Small-Medium-Large Connector, With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, M, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051171 ()
1137949

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Medium Connector, With Headgear, Global
Respironics, Inc.
DreamWisp Mask, Small, Med Connector w/Headgear, Global
In Commercial Distribution

  • 00606959051065 ()
1137933

  • CPAP/BPAP nasal mask, reusable
DreamStation BiPAP AVAPS 30 with Humidifier, with Heated Tubing, USA
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humid w/H Tube,US
In Commercial Distribution

  • 00606959040892 ()
DSX1130T11

  • Portable electric ventilator
AF811 Mask with Standard Elbow, with Headgear, Single Use, Large
Respironics, Inc.
AF811 Mask, w/SE, with Headgear, Large, Single Use
In Commercial Distribution

  • 00606959007680 ()
1063048

  • CPAP/BPAP face mask, single-use
AF811 Mask, with Standard Elbow, with Headgear, Single Use, Small
Respironics, Inc.
AF811 Mask, w/SE, w/Headgear, Small, Single Use
In Commercial Distribution

  • 00606959007666 ()
1063050

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow with CapStrap, Single Use, Large
Respironics, Inc.
AF531 Mask, SE with CapStrap, Large, Single Use
Not in Commercial Distribution

  • 00606959007291 ()
1061732

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask, SE with CapStrap, Medium, Single Use
Not in Commercial Distribution

  • 00606959007284 ()
1061731

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask, SE with CapStrap, Small, Single Use
Not in Commercial Distribution

  • 00606959007277 ()
1061730

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal, Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Large, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057265 ()
1137945AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Small with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Small, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057241 ()
1137943AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Petite with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057234 ()
1137942AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Extra Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, XL, S-M-L Connector w/Hdgr, JN
Not in Commercial Distribution

  • 00606959051195 ()
1137951

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051164 ()
1137948

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Petite with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051157 ()
1137947

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Large with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Large, Med Connector, w/Headgear, INTL
In Commercial Distribution

  • 00606959051133 ()
1137945

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Small, Med Connector, w/Headgear, INTL
In Commercial Distribution

  • 00606959051119 ()
1137943

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Petite with Medium Connector, With Headgear, Global
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, Global
In Commercial Distribution

  • 00606959051058 ()
1137932

  • CPAP/BPAP nasal mask, reusable
REMstar SE Auto, with Heated Humidifier, with SD Slot, Domestic
Respironics, Inc.
REMstar SE Auto, w/Heated Tube Humid and SD Slot, US
In Commercial Distribution

  • 00606959037090 ()
DS520TS

  • Heated respiratory humidifier
  • Home CPAP unit
REMstar SE Auto with Heated Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Heated Humidifier, w/SD Slot, CA
In Commercial Distribution

  • 00606959036765 ()
CA521TS

  • Home CPAP unit
  • Heated respiratory humidifier
AF531 Mask with Entrainment Elbow, Leak1, with CapStrap, China, Large
Respironics, Inc.
AF531 Mask EE, Leak1 with CapStrap, Large, China
In Commercial Distribution

  • 30606959027818 ()
  • 00606959027817 ()
1126275

  • CPAP/BPAP face mask, single-use
Performatrak Mask with Standard Elbow, with Headgear, Disposable, Small, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, SMALL, KR
Not in Commercial Distribution

  • 30606959027696 ()
  • 00606959027695 ()
1119724

  • CPAP/BPAP face mask, single-use
DreamWear Gel Pillows Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026780 ()
1124984

  • CPAP/BPAP nasal mask, reusable
Wisp Pediatric Mask Fitpack with Headgear, with Entrainment Elbow, International
Respironics, Inc.
Wisp Pediatric Fitpack with Headgear, EE, INTL
In Commercial Distribution

  • 00606959026735 ()
1104961

  • CPAP/BPAP nasal mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Medium, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Medium, JP
In Commercial Distribution

  • 00606959024786 ()
1090653

  • CPAP/BPAP face mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959024589 ()
  • 00606959024588 ()
1121072

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Small
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959024565 ()
  • 00606959024564 ()
1121070

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Capstrap, Large
Respironics, Inc.
AF541 Mask, EE, Leak 1 with Capstrap, Large
In Commercial Distribution

  • 30606959024503 ()
  • 00606959024502 ()
1121494

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium
Respironics, Inc.
AF541 Mask, EE, Leak 1 with Capstrap, Medium
In Commercial Distribution

  • 30606959024497 ()
  • 00606959024496 ()
1121493

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CAPSTRAP, Small
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Small, US
In Commercial Distribution

  • 30606959024404 ()
  • 00606959024403 ()
1121062

  • CPAP/BPAP face mask, single-use
DreamStation Cellular Modem with Oximetry, Europe, with PRI Label, Rental
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, PRI, EU
Not in Commercial Distribution

  • 00606959022867 ()
100620C

  • Medical networking interface unit
DreamStation CPAP with Humidifier, with Heated Tube, American Home Patient
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, AHP
Not in Commercial Distribution

  • 00606959022393 ()
AHX200T11

  • Home CPAP unit
DreamStation Auto BiPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, LA
In Commercial Distribution

  • 00606959028593 ()
LAX700T15

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, Latin America
In Commercial Distribution

  • 00606959028562 ()
LAX600T15

  • Home BPAP unit
DreamStation Auto CPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto CPAP w/Humidifier, w/H Tube, LA
In Commercial Distribution

  • 00606959028531 ()
LAX500T15

  • Home CPAP unit
DreamStation CPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, LA
In Commercial Distribution

  • 00606959028500 ()
LAX400T15

  • Home CPAP unit
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, LARGE
In Commercial Distribution

  • 30606959028440 ()
  • 00606959028449 ()
1126378

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE
Not in Commercial Distribution

  • 30606959028433 ()
  • 00606959028432 ()
1126377

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, MEDIUM
In Commercial Distribution

  • 30606959028426 ()
  • 00606959028425 ()
1126376

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK, WITH STANDARD ELBOW WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM
Not in Commercial Distribution

  • 30606959028419 ()
  • 00606959028418 ()
1126375

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, SMALL
In Commercial Distribution

  • 30606959028402 ()
  • 00606959028401 ()
1126374

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL
Not in Commercial Distribution

  • 30606959028396 ()
  • 00606959028395 ()
1126373

  • CPAP/BPAP face mask, single-use
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