FDA.reportPublic FDA data

Critical Cover

Primary DI
2081758302189
Brand
Critical Cover
Company
ALPHA PRO TECH INC
Model
WH1155
Catalog number
WH1155
Device description
POSITIVE FACIAL LOCK, EARLOOP, WHITE
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
2081758302189PackageGS110In Commercial Distribution
20817583021896PackageGS110In Commercial Distribution
10817583020182PrimaryGS10
00817583020185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302189020817583021892081758302189
2081758302189620817583021896
1081758302018210817583020182
00817583020185008175830201858175830201850817583020185

GMDN Terms#

Term, Definition table
TermDefinition
Surgical face mask, single-useA device intended to be placed over the nose and mouth of medical personnel to prevent the transmission of airborne organisms during surgery or patient examination. It is made of a flexible porous fabric material that allows the user to breath normally through the mask and typically includes a metal wire along one border to form fit the nose bridge; it is typically held in place with ties that fasten at the back of the user's head. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-355-5816XXX@XX.XX

Regulatory Flags#

DUNS number
003687733
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20817583020752Critical Cover SH-71222-B SH-71222-B2018-07-16
20817583020769Critical CoverSH-71223-BSH-71223-B2018-07-16
20817583020776Critical Cover SH-91182-B SH-91182-B2018-07-16
20817583020790Critical Cover SH-91183-B SH-91183-B2018-07-16
20817583020813Critical Cover SH-91184-B SH-91184-B2018-07-16
20817583020837Critical Cover SH-C1103-B SH-C1103-B2018-07-16
20817583020844Critical Cover SH-E1312-BH SH-E1312-BH2018-07-16
20817583020868Critical Cover SH-E1315-BH SH-E1315-BH2018-07-16
20817583020882Critical Cover SH-E1712-BH SH-E1712-BH2018-07-16
20817583020899Critical Cover SH-E1713-BH SH-E1713-BH2018-07-16
20817583020905Critical Cover SH-E1715-BH SH-E1715-BH2018-07-16
20817583020912Critical Cover SH-E1716-BH SH-E1716-BH2018-07-16
20817583020929Critical Cover SH-E1W11-BH SH-E1W11-BH2018-07-16
20817583020936Critical Cover SH-E1W12-BH SH-E1W12-BH2018-07-16
20817583020943Critical Cover SH-E1W13-BH SH-E1W13-BH2018-07-16
20817583020950Critical Cover SH-E1W15-BH SH-E1W15-BH2018-07-16
20817583020974Critical Cover SH-G1253-B SH-G1253-B2018-07-16
20817583020981Critical Cover SH-H1253-B SH-H1253-B2018-07-16
20817583021001Critical Cover SH-M1312-BH SH-M1312-BH2018-07-16
20817583021018Critical Cover SH-M1313-BH SH-M1313-BH2018-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30