FDA.reportPublic FDA data

COMBO

Primary DI
10817583020502
Brand
COMBO
Company
Alpha Pro Tech, Inc.
Model
SHI5194E
Catalog number
SHI5194E
Device description
EARLOOP MASKW/SHIELD AND SNAPS, BLUE 7 MIL.
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
FXXMask, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882027000COMBO-SHIELDBfd, Inc.1988-06-15FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817583020509PackageGS14In Commercial Distribution
10817583020502PrimaryGS10
00817583020505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081758302050920817583020509
1081758302050210817583020502
00817583020505008175830205058175830205050817583020505

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, single-useA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-520-281-0127XX@XX.XX

Regulatory Flags#

DUNS number
102710720
Device count
25
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
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
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09