FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850037921188
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHSFM1_CS
Catalog number
AHSFM1_CS
Device description
American Hospital Supply (AHS) Earloop Masks Disposable Case of 2000 (40 Boxes)
Published
2023-02-17
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
FXXMask, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202191000Surgical MaskWuhan Zonsen Medical Products Co., Ltd.2021-03-29FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037921188PrimaryGS10
00850046814471Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037921188008500379211888500379211880850037921188
00850046814471008500468144718500468144710850046814471

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
888-621-5011info@american-hospitalsupply.com

Regulatory Flags#

DUNS number
118098262
Device count
2000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810219420014American Hospital SupplyAHS-ESF_EAAHS-ESF_EA2026-06-09
00810219420038American Hospital SupplyAHS-ESA_EAAHS-ESA_EA2026-06-09
00810219420052American Hospital SupplyAHS-ESA_BXAHS-ESA_BX2026-06-09
00810219420069American Hospital SupplyAHS-ESA_CSAHS-ESA_CS2026-06-09
00810219420076American Hospital SupplyAHS-ESF_BXAHS-ESF_BX2026-06-09
00810219420083American Hospital SupplyAHS-ESF_CSAHS-ESF_CS2026-06-09
00850073571385American Hospital SupplyAHS-CS-KHBE-S-3_PKAHS-CS-KHBE-S-3_PK2026-06-09
00850073571392American Hospital SupplyAHS-CS-KHBE-S-3_CSAHS-CS-KHBE-S-3_CS2026-06-09
00850073571415American Hospital SupplyAHS-CS-KHBE-M-3_PKAHS-CS-KHBE-M-3_PK2026-06-09
00850073571422American Hospital SupplyAHS-CS-KHBE-M-3_CSAHS-CS-KHBE-M-3_CS2026-06-09
00850073571446American Hospital SupplyAHS-CS-KHBE-L-3_PKAHS-CS-KHBE-L-3_PK2026-06-09
00850073571453American Hospital SupplyAHS-CS-KHBE-L-3_CSAHS-CS-KHBE-L-3_CS2026-06-09
00850073571477American Hospital SupplyAHS-CS-KHBE-XL-3_PKAHS-CS-KHBE-XL-3_PK2026-06-09
00850073571484American Hospital SupplyAHS-CS-KHBE-XL-3_CSAHS-CS-KHBE-XL-3_CS2026-06-09
00850073571996American Hospital SupplyAHS-ESL_EAAHS-ESL_EA2026-06-09
00810219420090American Hospital SupplyAHS-ESL_BXAHS-ESL_BX2026-06-09
10810219420158American Hospital SupplyAHS-ES-1_BXAHS-ES-1_BX2026-04-27
00810219420137American Hospital SupplyAHS-PFS_CSAHS-PFS_CS2026-03-11
00810219420120American Hospital SupplyAHS-PFS_CSAHS-PFS_CS2026-03-11
00810219420106American Hospital SupplyAHS-ESL_CSAHS-ESL_CS2026-03-10

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Primary DI, Brand, Company table
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16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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