FDA.reportPublic FDA data

NOVAPLUS

Primary DI
20680651475972
Brand
NOVAPLUS
Company
O&M HALYARD, INC.
Model
47597
Catalog number
47597
Device description
Novaplus ASTM Fluid-Rated Fog-Free Procedure Mask, Blue, WrapAround Visor
Published
2019-05-16
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
K823078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823078000SPUNGUARD FACE MASKKimberly-Clark Corp.1983-01-07FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651475979PackageGS14In Commercial Distribution
20680651475972PrimaryGS10
90680651475971Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147597930680651475979
2068065147597220680651475972
9068065147597190680651475971

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, 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). 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.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04
20680651500681Halyard50068500682026-06-04
20680651500698Halyard50069500692026-06-04
20680651500704Halyard50070500702026-06-04
20680651500711Halyard50071500712026-06-04
20680651502388Halyard50238502382026-06-04
20680651502395Halyard50239502392026-06-04
20680651502401Halyard50240502402026-06-04
20680651502418Halyard50241502412026-06-04
20680651502425Halyard50242502422026-06-04
30680651424465Halyard42446NS42446NS2026-06-02
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
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