Home GUDID 10840216110929 ASP MEDICAL
Primary DI 10840216110929
Brand ASP MEDICAL
Company ASP GLOBAL, LLC
Model FMT605HEART
Device description MASK, LVL 2 FACE, BLUE W/HEARTS, EARLOOPS, 3-PLY, ASTM 1862, 50EA/BX, 40BX/CS (2000EA/CS)
Published 2022-02-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FXX Mask, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FXX Mask, Surgical General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10840216110929 Package GS1 50 In Commercial Distribution 20840216110926 Package GS1 2000 In Commercial Distribution 00840216110922 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10840216110929 10840216110929 20840216110926 20840216110926 00840216110922 00840216110922 840216110922 0840216110922
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 080361159 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850086117037 Resilient Medical Solutions Resilient Medical Solutions, LLC FXX 2026-07-08 00840456202722 JMU JMU DENTAL, INC FXX 2026-07-07 00840456202739 JMU JMU DENTAL, INC FXX 2026-07-07 00840456202746 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214619 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214626 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214633 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214640 JMU JMU DENTAL, INC FXX 2026-07-07 00840456214657 JMU JMU DENTAL, INC FXX 2026-07-07 00850056441261 Target Up&Up Armbrust Inc. FXX 2026-06-25 00850056441254 Target Up&Up Armbrust Inc. FXX 2026-06-25 16980077680262 AOK AOK TOOLING LIMITED FXX 2026-06-24 16980077680255 AOK AOK TOOLING LIMITED FXX 2026-06-22 00842942008894 PRIMED priMED Medical Products Inc FXX 2026-06-21 06922820992584 Graid Rfx+Care Manufacturing Co., Ltd. FXX 2026-06-09 16980077680217 AOK AOK TOOLING LIMITED FXX 2026-06-08 16980077680224 AOK AOK TOOLING LIMITED FXX 2026-06-08 16980077680231 AOK AOK TOOLING LIMITED FXX 2026-06-08 16980077680248 AOK AOK TOOLING LIMITED FXX 2026-06-08 16980077680170 AOK AOK TOOLING LIMITED FXX 2026-06-05 16980077680187 AOK AOK TOOLING LIMITED FXX 2026-06-05 16980077680194 AOK AOK TOOLING LIMITED FXX 2026-06-05 16980077680200 AOK AOK TOOLING LIMITED FXX 2026-06-05 16980077680149 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680156 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680163 AOK AOK TOOLING LIMITED FXX 2026-06-04 16980077680101 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680118 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680125 AOK AOK TOOLING LIMITED FXX 2026-06-03 16980077680132 AOK AOK TOOLING LIMITED FXX 2026-06-03