AccessGUDID - DEVICE: Defender (00863342000318)

GUDID

Device Identifier (DI) Information

Brand Name: Defender
Version or Model: D11NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Health Mor At Home Cbp

Primary DI Number: 00863342000318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146535 *Terms of Use

Device Description: The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18113	High-efficiency filter air cleaner, mobile	A mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRF	Cleaner, Air, Medical Recirculating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010616	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b4ee606-76e9-4424-9b95-deed108c69df
Public Version Date: March 19, 2021
Public Version Number: 1
DI Record Publish Date: March 11, 2021