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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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55" 24 Hour Smallbore Ext Set w/Bravo 24®, 2 Clamps, Rotating Luer
ICU MEDICAL, INC.
B9977
In Commercial Distribution

  • 10887709019895 ()
  • 00887709019898 ()


  • Basic intravenous administration set, noninvasive
Fantasy Assorted case of 12-packs (24 Lubricated, 24 3 Styles Assorted)( case of 48)
GLOBAL PROTECTION CORP.
L610002C
In Commercial Distribution

  • 80726893114018 ()
  • 20726893114016 ()


  • Basic male condom, Hevea-latex
U5 ALIAS LINGUAL 18 0/0/0
ORMCO CORPORATION
369-0050
In Commercial Distribution

  • 20889989080630 ()
  • 00889989080636 ()

  • Slot size 018, Torque 0, Angulation 0


  • Orthodontic bracket, metal
L6 ALIAS LINGUAL 18 0/0/0
ORMCO CORPORATION
369-0080
In Commercial Distribution

  • 20889989080661 ()
  • 00889989080667 ()

  • Slot size 018, Torque 0, Angulation 0


  • Orthodontic bracket, metal
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 00850022464577 ()
  • 10850022464574 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.
Miris AB
Miris HMA US
In Commercial Distribution

  • 27350107530076 ()
  • 17350107530079 ()
08-02-107

  • Breast milk analyser IVD
67-2586-0100-01 is an electronic file. There is no packaging.
ICU MEDICAL, INC.
67-2586-0100-01
In Commercial Distribution

  • 15019517130928 ()

  • Outer Diameter: 0 Millimeter
  • Length: 0 Millimeter
  • Width: 0 Millimeter
  • Circumference: 0 Millimeter
  • 0
  • Depth: 0 Millimeter


  • Infusion pump medication-dosage application software
KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC
SPACELABS HEALTHCARE (WASHINGTON), INC
Xhibit Central
In Commercial Distribution

  • 10841522127052 ()
040-1429-04

  • Electrocardiography monitoring system receiver
KIT,DUAL ANT,ACTV,W/O PS,UHF,HI LVL,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522124754 ()
040-0388-02

  • Electrocardiography monitoring system receiver
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