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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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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, Medium
Respironics, Inc.
AF541 Mask, EE, Leak 1 with Capstrap, Medium
In Commercial Distribution

  • 30606959024497 ()
  • 00606959024496 ()
1121493

  • 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
Wisp Mask, Clear Frame, with Headgear, with Standard Elbow, International
Respironics, Inc.
Wisp Mask, Clear Frame, with Headgear, w/SE, INTL
In Commercial Distribution

  • 00606959021280 ()
1094062

  • CPAP/BPAP nasal mask, reusable
BC-700 CHARGER - FITTED WITH CA-703 FOR USE WITH AB-703/704
DE SOUTTER MEDICAL LIMITED
16230
In Commercial Distribution

  • 05051471152281 ()
16230

  • Noninvasive device battery charger
BC-700 CHARGER - FITTED WITH CA-701 FOR USE WITH AB-701/702
DE SOUTTER MEDICAL LIMITED
16210
In Commercial Distribution

  • 05051471124639 ()
16210

  • Noninvasive device battery charger
BC-700 CHARGER - FITTED WITH CA-702 FOR USE WITH AB-450/600
DE SOUTTER MEDICAL LIMITED
16200
Not in Commercial Distribution

  • 05051471124622 ()
16200

  • Noninvasive device battery charger
Speedlock Grasper, 5mm with spoon, pointed version, 45cm, with ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-25-45-R
In Commercial Distribution

  • 00848657072755 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Duval, 10mm with axial serrations, 40mm jaws, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-41-45-R
In Commercial Distribution

  • 00848657002523 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Duval, 10mm with axial serrations, 40mm jaws, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-41-26-R
In Commercial Distribution

  • 00848657002516 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Wave Grasper DG, 5mm with atraumatic wave-like serrations with Rat
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-37-R
In Commercial Distribution

  • 00848657005906 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Retraction Forceps with atraumatic inner teeth, 5mm, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8512-37-45-R
In Commercial Distribution

  • 00848657005081 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Biopsy Spoon, 5mm, with teeth double action, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-10-26-R
In Commercial Distribution

  • 00848657001434 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Feeding set for use with CORFLO cuBBy with ENFit connectors
CORPAK MEDSYSTEMS, INC.
56-9024
Not in Commercial Distribution

  • 20815149022882 ()
  • 10815149022885 ()

  • Length: 24 Inch
  • 24" (61cm)
56-9024

  • Enteral tube extension, single-use
Feeding set for use with CORFLO cuBBy with ENFit connectors
CORPAK MEDSYSTEMS, INC.
56-9012
Not in Commercial Distribution

  • 20815149022875 ()
  • 10815149022878 ()

  • 12" (30cm)
  • Length: 12 Inch
56-9012

  • Enteral tube extension, single-use
PEG Safety Kit with ENFit Connectors Pull Technique with snare
CORPAK MEDSYSTEMS, INC.
50-5320-S7
In Commercial Distribution

  • 20815149021519 ()
  • 10815149021512 ()

  • Catheter Gauge: 20 French
  • 20 FR (6.7mm)
50-5320-S7

  • Gastrostomy tube
Jejunal tube with ENFit Connectors with 3 g weight stylet
CORPAK MEDSYSTEMS, INC.
51-7368
In Commercial Distribution

  • 20815149020833 ()
  • 10815149020836 ()

  • Catheter Gauge: 8 French
  • 8 FR (2.7mm) X 36" (91cm)
  • Length: 8 Inch
51-7368

  • Jejunostomy tube
Jejunal tube with ENFit Connectors with 3 g weight stylet
CORPAK MEDSYSTEMS, INC.
51-7361
In Commercial Distribution

  • 20815149020819 ()
  • 10815149020812 ()

  • Length: 36 Inch
  • 10 Fr (3.3mm) x 36" (91 cm)
  • Catheter Gauge: 10 French
51-7361

  • Jejunostomy tube
Neonatal Feeding tube with ENFit connectors non weighted with stylet
CORPAK MEDSYSTEMS, INC.
42-9226
In Commercial Distribution

  • 20815149020635 ()
  • 10815149020638 ()

  • Length: 22 Inch
  • Catheter Gauge: 6 French
  • 6FR (2mm) X 22" (56cm)
42-9226

  • Nasogastric feeding tube
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