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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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600 lb. Smart Lift® without scale, Standard
EZ Way, Inc.
L600PN-02
In Commercial Distribution

  • 00848914000064 ()


  • Mobile patient lifting system, electrically-powered
500 lb. Smart Lift® with scale, Standard
EZ Way, Inc.
L500PS-02
In Commercial Distribution

  • 00848914000057 ()


  • Mobile patient lifting system, electrically-powered
500 lb. Smart Lift® without scale, Standard
EZ Way, Inc.
L500PN-02
In Commercial Distribution

  • 00848914000040 ()


  • Mobile patient lifting system, electrically-powered
1,000 lb. Smart Lift® with scale, Standard
EZ Way, Inc.
L1000PS-02
In Commercial Distribution

  • 00848914000033 ()


  • Mobile patient lifting system, electrically-powered
1,000 lb. Smart Lift® without scale, Standard
EZ Way, Inc.
L1000PN-02
In Commercial Distribution

  • 00848914000026 ()


  • Mobile patient lifting system, electrically-powered
600 lb. Smart Lift® with scale, Standard
EZ Way, Inc.
L600PS-02
In Commercial Distribution

  • 00848914000019 ()


  • Mobile patient lifting system, electrically-powered
EchoOne, H-F, 2D
MEDICAL POSITIONING, INC.
4252
In Commercial Distribution

  • 00848871001371 ()


  • Multi-purpose diagnostic imaging table
EchoOne, H-F, 0D
MEDICAL POSITIONING, INC.
4052
In Commercial Distribution

  • 00848871001258 ()


  • Multi-purpose diagnostic imaging table
EchoOne, H-F, 1D
MEDICAL POSITIONING, INC.
4152
In Commercial Distribution

  • 00848871001203 ()


  • Multi-purpose diagnostic imaging table
The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate. The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle. The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.
REMEL, INC.
V3020
In Commercial Distribution

  • 00848838097409 ()


  • Antimicrobial susceptibility analyser IVD
No Description
REMEL, INC.
T3441
In Commercial Distribution

  • 00848838091360 ()


  • Culture medium antimicrobial supplement IVD
No Description
REMEL, INC.
T3450
In Commercial Distribution

  • 00848838091353 ()


  • Culture medium antimicrobial supplement IVD
No Description
REMEL, INC.
T3491
In Commercial Distribution

  • 00848838091322 ()


  • Isotonic saline reagent IVD
CARY-BLAIR ORANGE / EMPTY VL PK/120 SET
REMEL, INC.
R31949
Not in Commercial Distribution

  • 00848838090752 ()
R31949

  • General specimen collection kit IVD, clinical
Cary-Blair Orange w/Ind (15ml Vi) PK/12
REMEL, INC.
R31610
In Commercial Distribution

  • 00848838090622 ()
R31610

  • General specimen collection kit IVD, clinical
Cary-Blair Orange w/Ind (15ml Vi) PK/120
REMEL, INC.
R31925
In Commercial Distribution

  • 00848838090530 ()
R31925

  • General specimen collection kit IVD, clinical
CARY-BLAIR ORANGE W/O SPOON (15ML) PK/12
REMEL, INC.
R31620
Not in Commercial Distribution

  • 00848838090394 ()
R31620

  • General specimen collection kit IVD, clinical
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
RapID STAPH PLUS QC Set/4
REMEL, INC.
R4653047
Not in Commercial Distribution

  • 00848838072529 ()
R4653047

  • Bacterial species differentiation disc IVD
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