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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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BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Japan
Respironics, Inc.
BiPAP Auto BiFlex w/HT Humid System One 60 Series, JP
Not in Commercial Distribution

  • 00606959031876 ()
JP766TS

  • Home BPAP unit
BiPAP autoSV Advanced System One 60 Series with Heated Tube Humidifier, Canada
Respironics, Inc.
BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CA
Not in Commercial Distribution

  • 00606959014237 ()
CA961TS

  • Portable electric ventilator
BiPAP autoSV Advanced with Heated Tube Humidifier, System One 60 Series, US
Respironics, Inc.
BiPAP autoSV Advanced w/H Tube Humid, 60 Series, US
Not in Commercial Distribution

  • 00606959012530 ()
DS960TS

  • Portable electric ventilator
Oxygen Tubing 3-channel with one thread grip end 2 ft (24”), vinyl
SALTER LABS
PRO2-2
In Commercial Distribution

  • 00607411915987 ()
PRO2-2

  • Respiratory oxygen monitor, battery-powered
Main device 1ea, Single Hose 1ea, Double Hose 1ea [One set box]
DAESUNG MAREF CO.,LTD.
LF90200-2
In Commercial Distribution

  • 18809315676813 ()
  • 08809315676816 ()


  • Intermittent venous compression system
ostium seeker, w/ double-ended ball tips, frontal sinus, one end 90 degrees
NOVO SURGICAL, INC.
E7499-31
In Commercial Distribution

  • 00842331149856 ()
E7499-31

  • Mastoid gauge
Periosteal Elevators Kit 10 pcs periosteum elevator all designs in one set
Wise Linkers, LLC
242119
In Commercial Distribution

  • D1272421191 ()
1

  • Dental elevator, tooth/root
Main device 1ea, Tubing (81cm) 2ea, Tubing (102cm) 2ea [One set box]
DAESUNG MAREF CO.,LTD.
DVTP200-2
In Commercial Distribution

  • 18809802644455 ()
  • 08809802644458 ()


  • Sequential venous compression system
Needle Hldr,5mm c 33cm, One Pc,Axial Handl Jaws Cv Lft
FLEXBAR MACHINE CORPORATION
91594-AX
In Commercial Distribution

  • 00842102112065 ()


  • Externally-anchored laparoscopic retractor
LANE Bone Lever, curved, 10", (255 mm), one ring handle, non-sterile, reusable
Aesculap AG
FK136R
In Commercial Distribution

  • 04038653044931 ()
FK136R

  • Open-surgery dissector
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