CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890022131
• Version / Model: 712057462213
• Catalog Number: 9002213
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 023812d3-2c6e-42e5-a9b3-c47f7c225b87

Device Description

SURGICAL MASK, ANTI-FOG ADHESIVE TAPE, GREEN 80MM HG

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35177	Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20890022131	HIBCC
Unit of Use	M20890022130	HIBCC
Package	M20890022132	HIBCC	50/BOX 6BOX/CS	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081633	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			LEVEL 1 BARRIER PROTECTION 80 MM HG

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Open box should be shielded from exposure to direct sunlight, intense artificial light, x-ray machines and other sources of ozone.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.