Home GUDID 10850022371476 PrimaPro
Primary DI 10850022371476
Brand PrimaPro
Company PRIMARY PRODUCTS COMPANY
Model W182028EL-BX
Device description PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
Published 2020-09-18
Public version status Update
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 10850022371476 Package GS1 10 In Commercial Distribution 00850022371479 Primary GS1 0 20850022371473 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850022371476 10850022371476 00850022371479 00850022371479 850022371479 0850022371479 20850022371473 20850022371473
GMDN Terms# Term, Definition table Term Definition Isolation gown, single-use A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
Regulatory Flags# DUNS number 089569581 Device count 50 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 false Expiration date on label false Donation ID number false Contains natural rubber latex false 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 00850054870704 BAYLAB USA Baylab USA, LLC FXX 2026-10-01 G539MM3S1 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3S2 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3SB1 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 G539MM3SB2 Saf-T-Gard Saf-T-Gard International, Inc. FXX 2026-09-21 00050428143315 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FXX 2026-09-18 00050428340561 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FXX 2026-09-18 10304040195472 Essentials HENRY SCHEIN, INC. FXX 2026-09-04 10304040195489 Essentials HENRY SCHEIN, INC. FXX 2026-09-04 00810194402623 Aira AIRA, LLC FXX 2026-08-26 20197344219237 MEDLINE MEDLINE INDUSTRIES, INC. FXX 2026-07-31 06974960061330 S&J Xiantao S&J Protective Products Co., Ltd FXX 2026-07-29 00840456202814 JMU JMU DENTAL, INC FXX 2026-07-24 00840456202807 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214664 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214671 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214688 JMU JMU DENTAL, INC FXX 2026-07-23 00840456214695 JMU JMU DENTAL, INC FXX 2026-07-23 30197344201697 MEDLINE MEDLINE INDUSTRIES, INC. FXX 2026-07-20 00810145950975 NeuMask Pink Medgluv Inc. FXX 2026-07-17 00850005229728 NeuMask Orange Medgluv Inc. FXX 2026-07-17 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