FDA.reportPublic FDA data

Hedy SofMask

Primary DI
D903410MW2
Brand
Hedy SofMask
Company
Hedy Canada
Model
410MW
Catalog number
410MW
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D903410MW2PackageHIBCC6In Commercial Distribution
D903410MW1PrimaryHIBCC0
D903410MW0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905.271.1523HAMED@HEDYGS.COM

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 DIBrandModelCatalogPublished
D903410MB2Hedy SoftMask410MB410MB2018-11-23
D903410MG2Hedy SoftMask410MG410MG2018-11-23
D903410MP2Hedy SoftMask410MP410MP2018-11-23
D903420HFB2Hedy SoftMask420HFB420HFB2018-11-23
D903420HFG2Hedy SoftMask420HFG420HFG2018-11-23
D903420HFP2Hedy SoftMask420HFP420HFP2018-11-23
D903420HFW2Hedy SoftMask420HFW420HFW2018-11-23
D903420LFB2Hedy SoftMask420LFB420LFB2018-11-23
D903420LFG2Hedy SoftMask420LFG420LFG2018-11-23
D903420LFP2Hedy SoftMask420LFP420LFP2018-11-23
D903420LFW2Hedy SoftMask420LFW420LFW2018-11-23
D903430HVB2Hedy SoftMask430HVB430HVB2018-11-23
D903610HSP102HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-10610HSP-102019-01-17
D903610HSP202HedySeal PRO Self-Sealing Sterilization Pouches610HSP-20610HSP-202019-01-17
D903610HSP302HedySeal PRO Self-Sealing Sterilization Pouches610HSP-30610HSP-302019-01-17
D903610HSP402HedySeal PRO Self-Sealing Sterilization Pouches610HSP-40610HSP-402019-01-17
D903610HSP502HedySeal PRO Self-Sealing Sterilization Pouches610HSP-50610HSP-502019-01-17
D903610HSP602HedySeal PRO Self-Sealing Sterilization Pouches610HSP-60610HSP-602019-01-17
D903HEBEHO11Elements by Hedy Barrier EnvelopesHE-BEHO1HE-BEHO12019-03-18
D903HEBEHO21Elements by Hedy Barrier EnvelopesHE-BEHO2HE-BEHO22019-03-18

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