FDA.reportPublic FDA data

Vitacore

Primary DI
00628678429031
Brand
Vitacore
Company
Vitacore Industries Inc
Model
CAN99 9500
Published
2024-09-05
Public version status
New
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
MSHRespirator, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628678429055PackageGS125In Commercial Distribution
00628678429031PrimaryGS10
00628678429017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628678429055006286784290556286784290550628678429055
00628678429031006286784290316286784290310628678429031
00628678429017006286784290176286784290170628678429017

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-888-593-2218info@vitacore.com

Regulatory Flags#

DUNS number
204197628
Device count
25
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628678429024VitacoreCAN99 95002024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086001469732RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
00860014697333RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
10326053123457Regard™Resource Optimization & Innovation, L.L.C.MSH2026-03-18
00817169029649Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMSH2026-03-05
00860014697302RiskWise SuppliesRiskWise Supplies LLCMSH2026-02-17
00860014697319RiskWise Supplies RiskWise Supplies LLCMSH2026-02-17
20680651492993HalyardO&M HALYARD, INC.MSH2025-09-30
20680651493006HalyardO&M HALYARD, INC.MSH2025-09-30
00639890596333RadnorLOUIS M. GERSON CO.MSH2025-04-14
00764423027777FastlineLOUIS M. GERSON CO.MSH2025-04-14
00850019086157Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096427MedavaLOUIS M. GERSON CO.MSH2025-04-14
00044585817301FastlineLOUIS M. GERSON CO.MSH2025-04-14
10850019086154Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096434MedavaLOUIS M. GERSON CO.MSH2025-04-14
00781311086104SAS Safety / GersonBunzl USA Holdings LLCMSH2025-04-04
10016659570150All Pro Bunzl USA Holdings LLCMSH2025-04-04
00850017658288SHIELDLWS HEALTH & SAFETY LLCMSH2025-02-11
00850017658264Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2025-02-11
00850056748070FORWARD Enforcement Group Medical BagINTEGRATED MEDCRAFT LLCMSH2024-10-04
00628678429024VitacoreVitacore Industries IncMSH2024-09-05
20197344019530MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
30197344019537MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
00852212003696ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
10852212003693ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
16946276000010Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
06946276000013Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
00044585333016GERSONLOUIS M. GERSON CO.MSH2024-01-12
00044585833301GERSONLOUIS M. GERSON CO.MSH2024-01-12
06924997807876Makrite Industries Inc.DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.MSH2023-09-28