FDA.reportPublic FDA data

Critical Cover

Primary DI
10817583020144
Brand
Critical Cover
Company
Alpha Pro Tech, Inc.
Model
695MED
Catalog number
695MED
Device description
N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.
Published
2016-11-03
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
MSHRespirator,Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092824000N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695Alpha Protech, Inc.2009-10-21MSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817583020141PackageGS16In Commercial Distribution
10817583020144PrimaryGS10
00817583020147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302014120817583020141
1081758302014410817583020144
00817583020147008175830201478175830201470817583020147

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
1-520-281-0127XX@XX.XX

Regulatory Flags#

DUNS number
102710720
Device count
35
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817583020342Critical CoverSH-12524-BSH-12524-B2026-04-16
10817583020731Critical Cover SH-12522-B SH-12522-B2018-07-16
10817583020748Critical Cover SH-12523-B SH-12523-B2018-07-16
10817583020304Critical CoverGR5005GR50052016-11-03
10817583020311Critical CoverPK5005PK50052016-11-03
10817583020335Critical CoverBL5100BL51002016-11-03
10817583020564Critical CoverBL5500BL55002016-11-03
10817583020625Critical Cover1008 Biotrol1008 Biotrol2016-11-03
00817583020635Critical Cover1008 COTT BULK1008 COTT BULK2016-11-03
00817583020642Critical Cover1015 COTT BULK1015 COTT BULK2016-11-03
10817583020236Critical CoverGR6055GR60552016-11-03
10817583020137Critical Cover695CRX695CRX2016-11-03
10817583020243Critical CoverPK6055PK60552016-11-03
10817583020250Critical CoverYL6055YL60552016-11-03
10817583020595Critical CoverBL6155BENBL6155BEN2016-11-15
10817583020601Critcal CoverPK6155-BENPK6155-BEN2016-11-15
10817583020618Critical CoverWH6155BENWH6155BEN2016-11-15
10817583020687Critical Cover MS-01J76-4ST MS-01J76-4ST2018-07-16
10817583020694Critical Cover MS-01J76-8ST MS-01J76-8ST2018-07-16
10817583023329Critical Cover9400 Veil9400 Veil2020-12-18

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
00628678429031VitacoreVitacore 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