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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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AED Battery Exchange - 00864312000246

Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT. Color blue.
AED BATTERY EXCHANGE, LLC
9146-B-ABE
In Commercial Distribution

  • 00864312000246 ()


  • Primary battery

CORTAC® - 00650551063667

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2111-20-046
In Commercial Distribution

  • 00650551063667 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-20-046

  • Cortical electrode

Proov - 00850035206102

At home IVD LH tests (also called ovulation tests or OPKs) measure luteinizing hormone before ovulation to identify your two most fertile days.
Mfb Fertility, Inc.
Predict
In Commercial Distribution

  • 00850035206102 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Dosimeter Dosimax plus A - EIBAVD02017470

Single channel dosimeter according to IEC 61674, designed for acceptance tests and for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.
IBA Dosimetry GmbH
VD0201747
In Commercial Distribution

  • EIBAVD02017470 ()
VD0201747

  • Diagnostic x-ray system quality assurance device

DG Therm - 08437014205169

DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD

Resp-O2 Advantage Filter- Universal Respiratory B/V Filter - 00840117305861

Bacterial: 99.998%, Viral: 99.96%, Adult/Ped : Tidal Volume Range(150-1500mL), Breathing Resistance(1.4cm H2O at 60 L/min), Dead Space(45mL), Weight(21g)
Dynarex Corporation
30400
In Commercial Distribution

  • 00840117305878 ()
  • 00840117305861 ()


  • Heat/moisture exchanger insertable filter

Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube - 00840117305458

Adult, Tidal Volume Range(150-1500mL), Media(Foam), Dead Space(62 (34)mL), Breathing Resistance(3.0cm H2O at 60 L/min), Weight(24g), Adult
Dynarex Corporation
30204
In Commercial Distribution

  • 00840117305465 ()
  • 00840117305458 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter, CO2 Port and Flex - 00840117305359

Adult, Tidal Volume Range(250-1500mL), Media(Foam + Flat Media), Dead Space(89 (60)mL, Breathing Resistance(2.0cm H2O at 60L /min), Weight (45g)
Dynarex Corporation
30106
In Commercial Distribution

  • 00840117305366 ()
  • 00840117305359 ()


  • Heat/moisture exchanger/microbial medical gas filter

JOBST Elvarex - 04019702257236

Elvarex 2/Thigh High/Profile, Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77556-01163-00
In Commercial Distribution

  • 04019702257236 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702330748

Elvarex Forte 3/Thigh High/Slant, Closed Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77428-00459-00
In Commercial Distribution

  • 04019702330748 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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