Home GUDID D903420HFB2 Hedy SoftMask
Primary DI D903420HFB2
Brand Hedy SoftMask
Company Hedy Canada
Model 420HFB
Catalog number 420HFB
Device description Procedure Mask
Published 2018-11-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
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 D903420HFB2 Package HIBCC 6 In Commercial Distribution D903420HFB1 Primary HIBCC 0 D903420HFB0 Unit of Use HIBCC 0
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 249482399 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D903410MB2 Hedy SoftMask 410MB 410MB 2018-11-23 D903410MG2 Hedy SoftMask 410MG 410MG 2018-11-23 D903410MP2 Hedy SoftMask 410MP 410MP 2018-11-23 D903410MW2 Hedy SofMask 410MW 410MW 2018-11-23 D903420HFG2 Hedy SoftMask 420HFG 420HFG 2018-11-23 D903420HFP2 Hedy SoftMask 420HFP 420HFP 2018-11-23 D903420HFW2 Hedy SoftMask 420HFW 420HFW 2018-11-23 D903420LFB2 Hedy SoftMask 420LFB 420LFB 2018-11-23 D903420LFG2 Hedy SoftMask 420LFG 420LFG 2018-11-23 D903420LFP2 Hedy SoftMask 420LFP 420LFP 2018-11-23 D903420LFW2 Hedy SoftMask 420LFW 420LFW 2018-11-23 D903430HVB2 Hedy SoftMask 430HVB 430HVB 2018-11-23 D903610HSP102 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-10 610HSP-10 2019-01-17 D903610HSP202 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-20 610HSP-20 2019-01-17 D903610HSP302 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-30 610HSP-30 2019-01-17 D903610HSP402 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-40 610HSP-40 2019-01-17 D903610HSP502 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-50 610HSP-50 2019-01-17 D903610HSP602 HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-60 610HSP-60 2019-01-17 D903HEBEHO11 Elements by Hedy Barrier Envelopes HE-BEHO1 HE-BEHO1 2019-03-18 D903HEBEHO21 Elements by Hedy Barrier Envelopes HE-BEHO2 HE-BEHO2 2019-03-18
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809755250171 KP Protective Face Mask KP trading Co., Ltd. FXX 2026-02-19 10097604555514 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2025-07-28 10371347011606 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011613 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011620 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10097604543320 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604553022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604563229 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604573624 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10195327560522 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FXX 2023-12-21 10097604537022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10097604538128 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10304040169022 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169039 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169046 Criterion HENRY SCHEIN, INC. FXX 2023-07-05 10304040165253 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040165260 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168483 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168490 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168582 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168612 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168629 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168643 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168650 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168926 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168933 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168940 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10087701434423 Good Neighbor Shepard Medical Products, Inc. FXX 2023-01-06 10096295122296 Leader Shepard Medical Products, Inc. FXX 2023-01-06 10096295137382 Leader Shepard Medical Products, Inc. FXX 2023-01-06
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