FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850037921164
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHSFM1_BX
Catalog number
AHSFM1_BX
Device description
American Hospital Supply (AHS) Earloop Masks Disposable | Box of 50
Published
2023-02-17
Public version status
New
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

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
00850037921171PrimaryGS10
00850037921164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037921171008500379211718500379211710850037921171
00850037921164008500379211648500379211640850037921164

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-621-5011info@american-hospitalsupply.com

Regulatory Flags#

DUNS number
118098262
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
true
Expiration date on label
true
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
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
00810219420090American Hospital SupplyAHS-ESL_CSAHS-ESL_CS2026-03-10
00810219420113American Hospital SupplyAHS-PFS_EAAHS-PFS_EA2026-03-10
00850073571903American Hospital SupplyAHS-HOT-69_EAAHS-HOT-69_EA2026-03-10
00850073571088American Hospital SupplyAHS-ICE-69_CSAHS-ICE-69_CS2025-07-28
00850073571101American Hospital SupplyAHS-HCP-RE_PRAHS-HCP-RE_PR2025-07-28
00850073571118American Hospital SupplyAHS-HCP-RE_CSAHS-HCP-RE_CS2025-07-28
00850073571095American Hospital SupplyAHS-HCP-RE_EAAHS-HCP-RE_EA2025-07-10
00850073571071American Hospital SupplyAHS-ICE-69_EAAHS-ICE-69_EA2025-07-09
00850068404926American Hospital SupplyAHS-CS-KHB-S-3_CSAHS-CS-KHB-S-3_CS2025-07-28
00850068404957American Hospital SupplyAHS-CS-KHB-M-3_CSAHS-CS-KHB-M-3_CS2025-07-28
00850068404988American Hospital SupplyAHS-CS-KHB-L-3_CSAHS-CS-KHB-L-3_CS2025-07-28
00850073571019American Hospital SupplyAHS-CS-KHB-XL-3_CSAHS-CS-KHB-XL-3_CS2025-07-28
10850068404817American Hospital SupplyAHS-CS-KHB-S-3_CSAHS-CS-KHB-S-3_CS2025-07-28
10850068404831American Hospital SupplyAHS-CS-KHB-M-3_CSAHS-CS-KHB-M-3_CS2025-07-28
10850068404855American Hospital SupplyAHS-CS-KHB-L-3_CSAHS-CS-KHB-L-3_CS2025-07-28
10850068404879American Hospital SupplyAHS-CS-KHB-XL-3_CSAHS-CS-KHB-XL-3_CS2025-07-28

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Primary DI, Brand, Company table
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16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
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16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26