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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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Charger AC/DC with power cord - 09353645000098

Activox, Charger AC/DC with power cord
RESMED ASIA PTE. LTD.
XYC103
In Commercial Distribution

  • 09353645000098 ()


  • Basic power supply, reusable

EchoNous Samsung S8 Tablet with Software - 09353278000663

EchoNous (Uscan) Samsung S8 Tablet with Software
ECHONOUS, INC.
P007635
In Commercial Distribution

  • 09353278000663 ()


  • Hand-held ultrasound imaging system, body-surface

t:slim X2 Insulin Pump with Control-IQ - 00850006613779

t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare
Tandem Diabetes Care, Inc.
1006404
In Commercial Distribution

  • 00850006613779 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system

t:slim X2 Insulin Pump with Basal-IQ - 00850006613731

t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement
Tandem Diabetes Care, Inc.
1006379
In Commercial Distribution

  • 00850006613731 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system

t:slim X2 Insulin Pump with Control-IQ - 00850006613229

t:slim X2 Insulin Pump with Control-IQ, 7.x, Reconditioned
Tandem Diabetes Care, Inc.
1005012
In Commercial Distribution

  • 00850006613229 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system

API CORDED WITH BLUE FILTER ASSY - 05055272716765

No Description
KEELER LIMITED
1204-P-3102
In Commercial Distribution

  • 05055272716765 ()


  • Indirect binocular ophthalmoscope

BioButton At-Home Kit with Power Adaptor - 00850005949312

BioButton At-Home Kit with Power Adaptor
BIOINTELLISENSE, INC.
KIT-BBR-3763-1
In Commercial Distribution

  • 00850005949336 ()
  • 00850005949312 ()


  • Wearable multiple physiological parameter recorder, reusable

VORTRAN GO2VENT® with Peep Valve - 00637320061239

The VORTRAN GO2VENT® with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
VORTRAN MEDICAL TECHNOLOGY 1, INC
6123
In Commercial Distribution

  • 00637320061239 ()
  • 20637320061233 ()
6123

  • Pulmonary resuscitator, pneumatic, single-use

IVRO RETRACTOR, SLIDER WITH TWO KNOBS - D928910140010

No Description
W.H. Holden, Inc.
91-0140-01
In Commercial Distribution

  • D928910140010 ()


  • Surgical drill guide, reusable

CS Prone Plus Helmet - with bolts - 05060624124150

No Description
CARE SURGICAL LIMITED
CSM2565-3
In Commercial Distribution

  • 05060624124150 ()
CSM2565-3

  • Operating table patient positioning set, reusable
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