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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 BiPAP autoSV with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040564 ()
CAX900T12

  • Portable electric ventilator
DreamStation BiPAP autoSV with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidr w/H Tube, US
In Commercial Distribution

  • 00606959040533 ()
DSX900T11

  • Portable electric ventilator
Wisp Mask, with Fabric Frame, with Headgear, Large, International
Respironics, Inc.
Wisp Mask, Large, Fabric Frame, with Headgear, INTL
In Commercial Distribution

  • 00606959040076 ()
1094049

  • CPAP/BPAP nasal mask, reusable
Wisp Mask, with Clear Frame, with Headgear, Small-Medium, International
Respironics, Inc.
Wisp Mask, Small-Medium, Clear Frame, w/Headgear, INTL
In Commercial Distribution

  • 00606959040021 ()
1093924

  • CPAP/BPAP nasal mask, reusable
REMstar SE Auto with Humidifier, with SD Slot, Domestic
Respironics, Inc.
00
In Commercial Distribution

  • 00606959037083 ()
DS520HS

  • Home CPAP unit
  • Heated respiratory humidifier
800CC SUCTION CANISTER WITH HYDROPHOBIC FILTER WITH RED LID
BEMIS MANUFACTURING COMPANY
424410 10
Not in Commercial Distribution

  • 20073088149842 ()
  • 00073088149848 ()

  • Total Volume: 800 Milliliter
424410 10

  • Surgical suction system collection container, single-use
GEAR H-BASE WITH 3 POLE PUMP AD WITH QWIK-IT
PRYOR PRODUCTS
1100G-QK
In Commercial Distribution

  • 00761887004412 ()
1100G-QK

  • Freestanding/bed-attached intravenous pole
Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system
1.75Dia With Three .250 SlotsLight Handle Cover With Flange
DEROYAL INDUSTRIES, INC.
BE3-F
In Commercial Distribution

  • 50749756955268 ()
  • 00749756955263 ()


  • Instrument/equipment drape, single-use, sterile
Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper
COOK INCORPORATED
G17636
In Commercial Distribution

  • 00827002176362 ()
AQ-076012-TP

  • Endoscopic-access dilator, single-use
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