Hedy SoftMask 420HFP

GUDID D903420HFP2

Procedure Mask

Hedy Canada

Surgical/medical face mask, single-use
Primary Device IDD903420HFP2
NIH Device Record Key83656063-c0bd-440b-9459-2cf5cfdb3e43
Commercial Distribution StatusIn Commercial Distribution
Brand NameHedy SoftMask
Version Model Number420HFP
Catalog Number420HFP
Company DUNS249482399
Company NameHedy Canada
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD903420HFP0 [Unit of Use]
HIBCCD903420HFP1 [Primary]
HIBCCD903420HFP2 [Package]
Contains: D903420HFP1
Package: CASE [6 Units]
In Commercial Distribution

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2018-11-23

On-Brand Devices [Hedy SoftMask]

D903430HVB2Procedure Mask
D903420LFW2Procedure Mask
D903420LFP2Procedure Mask
D903420LFG2Procedure Mask
D903420LFB2Procedure Mask
D903420HFW2Procedure Mask
D903420HFP2Procedure Mask
D903420HFG2Procedure Mask
D903420HFB2Procedure Mask
D903410MP2Procedure Mask
D903410MG2Procedure Mask
D903410MB2Procedure Mask

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