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10 PER BOX MaskIT Diagnostic Guardian™

Item Number: DG-1225-10
$150.00

 

Why MaskIT?

Endoscopy is a critical part of the ENT examination which brings the doctor to within 20 inches of the patient. During ENT exams we increase the risk of exposure to infectious particles purely by examining an unprotected source. Endoscopy stimulates the nose and throat to possibly create an unpredictable and spontaneous cough, sneeze or gag which can expel infectious particles.

These events may be rare, but exposes everyone and the room to unpredictable infectious load. It is not practical nor fiscally responsible to test every patient for every illness prior to scoping. Asymptomatic false negative Covid patients exist; hence universal precautions are critical and have yet to be fully established.

MaskIT Diagnostic Guardian provides critical source protection to examiner, reduces exposure to the room and everyone in the room. 

10 masks per box

 

How It Works

The MaskIT Diagnostic Guardian™ is placed on patients prior to endoscopy procedures. After securing the mask to properly fit the patient, endoscopes can be inserted through the hole in the seal. The patient's nasal area can easily be visualized through the clear plastic fitting. 

Features

  • The MaskIT Diagnostic Guardian™ mask is the only scope mask combining a facial seal gasket and high filter material
  • Two masks available: one with 2.5mm opening, other with 3.5mm opening
  • 2.5mm mask (DG-1225-10) accommodates 2.0mm-3.1mm diameter endoscopes
  • 3.5mm mask (DG-1235-10) accommodates 3.2mm-4.0mm diameter endoscopes
  • Manufactured from a filtering face piece (materials include silicone, polypropylene, cotton, PET and elastomer strap)
  • Mounted with a clear polycarbonate housing adapter to hold a flexible medical grade silicone seal
  • Adjustable straps, tensioning clips and metal nosie bridge combine to provide a secure, tight, universal fit
  • Tested medical-grade silicone seals with sneeze pressure airtight seal
  • Patients feel more secure with masks on
  • Contains no natural rubber latex material
  • Disposable, single-use prevents contamination
  • 10 masks per box


Two Masks Available (10 Masks per Box)

  • Mask with 2.5mm opening (DG-1225-10) accommodates 2.0mm-3.1mm diameter endoscopes
  • Mask with 3.5mm opening (DG-1235-10) accommodates 3.2mm-4.0mm diameter endoscopes

 

What has COVID-19 taught us?

Scopes have been found to create aerosols consistent with speaking and breathing unless the patient has a spontaneous sneeze, cough, gag or cry.

Are you or your staff willing to take this risk?

  1. Be prepared by having reserve PPE
  2. Use universal precautions on ALL sick patients with any head and neck illness
  3. During a novel pandemic use universal precautions on all patients (sick or not) 

Inserting Endoscopy Through Mask


The use of extra PPE like the MaskIT Diagnostic Guardian™ during the covid crisis has resulted in the AMA approving the code 99072. This code has begun to see payment by some carriers.

MaskIT Diagnostic Guardian™ Documentation
(requires Adobe Acrobat Reader)
Advocate Physican Partners (EOB)
Bluecross Blueshied of Illinois (EOB)
Instructions for MaskIT Diagnostic Guardian™

 

WARNINGS:

  • Diagnostic Guardian™ is NOT an N95 Mask or intended for use as a surgical mask or a respirator and does not protect wearer.
  • Diagnostic Guardian™ is not intended to provide liquid barrier protection and is not a replacement for personal protective equipment and is not to be used in the presence of high intensity heat source or flammable gas.
  • This product is disposable and is intended for single use to prevent any contamination or cross contamination.
  • Diagnostic Guardian™ is meant solely as a source protection device and use of it does not remove the risk of infection or death from infection
  • This product should not be used in patients with sensitivity to its materials

 

*Note: The Diagnostic Guardian™ has been authorized by the FDA under an EUA for use as a source control by the general public as well as by health care providers in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.


The Diagnostic Guardian™ has not been FDA cleared or approved, and is authorized by the FDA under the EUA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as used as medical devices, during the COVID -19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. & 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. 

Patient Pending


SOLD TO MEDICAL PROFESSIONALS ONLY
The MaskIt Diagnostic Guardian™ is available for purchase by medical professionals and medical facilities only.
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