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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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EZCare™ Softouch - 10812594011464

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Large - Black
In Commercial Distribution

  • 00812594011467 ()
  • 10812594011464 ()
N926

  • Airway suction catheter

Ritter - 00841709118029

The Ritter Stainless Steel Treatment Pan is intended for lower-body procedures or other situations in which removal of fluid and debris is necessary.
MIDMARK CORPORATION
9A70000
In Commercial Distribution

  • 00841709118029 ()
9A70000

  • General examination/treatment chair, electric

Midmark - 00841709118012

The Ritter Caster Base is an accessory that is intended to convert the 253 LED Exam Light from a stationary to mobile light.
MIDMARK CORPORATION
9A628001
In Commercial Distribution

  • 00841709118012 ()
9A628001

  • General examination/treatment chair, electric

Midmark - 00841709117985

The Midmark Stainless Steel Treatment Pan is intended for lower-body procedures or other situations in which removal of fluid and debris is necessary.
MIDMARK CORPORATION
9A610001
In Commercial Distribution

  • 00841709117985 ()
9A610001

  • General examination/treatment chair, electric

xMAP® Sheath Concentrate PLUS - 00840487101780

A concentrated version of xMAP® Sheath Fluid PLUS, when diluted is is the delivery medium of the sample to the optics component.
LUMINEX CORPORATION
40-50036
In Commercial Distribution

  • 00840487101780 ()


  • Multiplex analyser IVD, laboratory

Capture-P Ready-Screen - 10888234001287

Capture-P Ready-Screen solid phase system is used to detect IgG HLA and platelet specific antibodies to platelets. This is a single microplate product.
IMMUCOR, INC.
0066247
In Commercial Distribution

  • 10888234001287 ()
0066247

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

Platelet Wash and Storage Solution - 10888234000488

Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
IMMUCOR, INC.
0005035
In Commercial Distribution

  • 10888234000488 ()
0005035

  • Platelet storage solution

Go Go Endurance AL+ - 00606509300858

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC54ALX
In Commercial Distribution

  • 00606509300858 ()
N/A

  • Assistive scooter, electric-motor-driven

Elite Traveller 2 Platinum - 00606509300841

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC442EMS
In Commercial Distribution

  • 00606509300841 ()
N/A

  • Assistive scooter, electric-motor-driven

RSC104 - 00606509300834

A motorized four-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
RSC104
Not in Commercial Distribution

  • 00606509300834 ()
N/A

  • Assistive scooter, electric-motor-driven
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