AccessGUDID - DEVICE: PM Excellence SEQUR 100 (10850037258083)

GUDID

Device Identifier (DI) Information

Brand Name: PM Excellence SEQUR 100
Version or Model: 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PM EXCELLENCE LLC DOO BEOGRAD

Primary DI Number: 10850037258083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 680785621 *Terms of Use

Device Description: PM Excellence SEQUR 100 is a flat pleated, 3-layer surgical face mask with non-latex elastic ear loops and malleable nose wire piece. Product Characteristics: • Three layers of breathable non-woven polypropylene fabric • Integrated shapeable nose wire for better fit • Non latex elastic ear loops for greater comfort • Non-cytotoxic, non-irritating and non-sensitizing • Single use, disposable, non-sterile • Provides full coverage, starting from the malleable component of the nose piece at the top all the way to the snug, yet comfortable fit under the chin.

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":	Yes
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?
66197	Surgical/medical face mask, antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220520	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: e7884855-4fc9-4121-a622-7ba2da27043e
Public Version Date: March 07, 2023
Public Version Number: 1
DI Record Publish Date: February 27, 2023