FDA.reportPublic FDA data

CUSTOMED

Primary DI
M20890022151
Brand
CUSTOMED
Company
CUSTOMED INC
Model
712057462215
Catalog number
9002215
Device description
PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081633000PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSPrimed Medical Products, Inc.2008-08-11FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20890022152PackageHIBCC4In Commercial Distribution
M20890022151PrimaryHIBCC0
M20890022150Unit 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Open box should be shielded from exprosure to direct sunlight, intense artificial light, x-ray machines and other sources of ozone.
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
787-622-5151customer.service@customedhealing.com

Regulatory Flags#

DUNS number
627572217
Device count
25
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2089004048C1CUSTOMED7120577000489004048C2023-08-10
M2089004049C1CUSTOMED7120577000499004049C2023-08-10
M2089004050C1CUSTOMED7120577000509004050C2023-08-10
M2089004051C1CUSTOMED7120577000519004051C2023-08-10
M20810063642CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029842CUSTOMED71205710298490029842023-08-10
M20890029852CUSTOMED71205710298590029852023-08-10
M20890029862CUSTOMED71205710298690029862023-08-10
M20890029872CUSTOMED71205710298790029872023-08-10
M20890029882CUSTOMED71205710298890029882023-08-10
M20890030922CUSTOMED71205710309290030922023-08-10
M20890030932CUSTOMED71205710309390030932023-08-10
M20890031442CUSTOMED71205710314490031442023-08-10
M20890040522CUSTOMED71205710405290040522023-08-10
M20890046941CUSTOMED71205701469490046942023-08-10
M20890046951CUSTOMED71205701469590046952023-08-10
M20810063640CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029840CUSTOMED71205710298490029842023-08-10
M20890029850CUSTOMED71205710298590029852023-08-10
M20890029860CUSTOMED71205710298690029862023-08-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
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10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
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10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
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