Home GUDID D1051013011 MacSafe
Primary DI D1051013011
Brand MacSafe
Company Surgimac LLC
Model 10-1301
Catalog number 101301
Device description MacSafe ASTM Level 1 Earloop Mask, BFE/PFE >98%, Blue, 50/Box
Published 2026-06-25
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 KHA Mask, Scavenging
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHA Mask, Scavenging Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D1051013011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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.
Regulatory Flags# DUNS number 060635048 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false 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 D1051013021 MacSafe Surgimac LLC KHA 2026-06-26 D1051013031 MacSafe Surgimac LLC KHA 2026-06-26 D1051013041 MacSafe Surgimac LLC KHA 2026-06-26 00816711024972 MATRX SCAV(WO/HOOD)WO/SHUTOFF PARKER-HANNIFIN CORPORATION KHA 2026-02-23 00810339030315 SAFE DENT BGSS Company Inc. KHA 2024-05-15 00810339031121 SAFE DENT BGSS Company Inc. KHA 2024-05-15 00810339030322 SAFE DENT BGSS Company Inc. KHA 2024-05-15 00810339031138 SAFE DENT BGSS Company Inc. KHA 2024-05-15 00813830027464 Axess CapnographyAdapters ACCUTRON, INC. KHA 2023-09-22 D974BSIBL011 Britedent Bright Supply, Inc. KHA 2023-09-18 D974BSIBL021 Britedent Bright Supply, Inc. KHA 2023-09-18 D974BSIBL012 Britedent Bright Supply, Inc. KHA 2023-09-18 D974BSIBL022 Britedent Bright Supply, Inc. KHA 2023-09-18 D1243I50NE0 Solidex Creo Dent Hudson Valley, Inc. KHA 2023-06-07 D1243I50TC0 Solidex Creo Dent Hudson Valley, Inc. KHA 2023-06-07 04260635790431 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790523 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790547 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790448 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790479 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790486 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790530 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790554 AirTechiques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790578 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790585 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790592 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 04260635790608 AirTechniques Baldus Sedation GmbH & Co. KG KHA 2023-01-05 16975316480031 BESTAR WUHAN BESTAR INDUSTRY CO.,LTD KHA 2022-12-19 06933192201112 Hakuna Matata FUJIAN BBC INC KHA 2022-12-07 00816711020769 Matrx Scavenger Large Nasal Inhaler PARKER-HANNIFIN CORPORATION KHA 2022-12-06