FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850037921775
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHS-SP-3510_BX
Catalog number
AHS-SP-3510_BX
Device description
AHS Sterilization Pouch, 3.5'' x 10'', Box of 200
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153540000Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.2016-08-04FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037921775PrimaryGS10
00850046814419Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037921775008500379217758500379217750850037921775
00850046814419008500468144198500468144190850046814419

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
118098262
Device count
200
Lot or batch
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
Primary DIBrandCompanyProduct codePublished
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
00859464007748Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
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00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
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