FDA.reportPublic FDA data

Reliance Fusion Heavy

Primary DI
00841982101848
Brand
Reliance Fusion Heavy
Company
AHLSTROM NONWOVENS LLC
Model
FH04040
Device description
WLJ2HZ132B, Sterilization Wrap, Reliance Fusion Heavy, Blue and green bonded alternating sheets, 40 x 40 inches [] 72 applications per case. As used, blue sheet is outer layer.
Published
2024-03-11
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230137000Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC2023-12-07FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841982101855PrimaryGS10
00841982101848Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841982101855008419821018558419821018550841982101855
00841982101848008419821018488419821018480841982101848

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8606548300medical@ahlstrom.com

Regulatory Flags#

DUNS number
039993345
Device count
72
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00841982101923Sterilization Wrap, Reliance Solo S600WLJ2Z1170B452024-04-11
00841982101930Sterilization Wrap, Reliance Solo S600WLJ2Z1170B452024-04-11
00841982101893Reliance Fusion HeavyFH054542024-03-12
00841982101886Reliance Fusion HeavyFH054542024-03-12
00841982101534Reliance Fusion LightFL012122024-03-11
00841982101558Reliance Fusion LightFL015152024-03-11
00841982101572Reliance Fusion LightFL018182024-03-11
00841982101596Reliance Fusion LightFL024242024-03-11
00841982101619Reliance Fusion LightFL030302024-03-11
00841982101633Reliance Fusion LightFL036362024-03-11
00841982101657Reliance Fusion LightFL040402024-03-11
00841982101671Reliance Fusion LightFL048482024-03-11
00841982101695Reliance Fusion LightFL054542024-03-11
00841982101718Reliance Fusion LightFL054702024-03-11
00841982101794Reliance Fusion HeavyFH024242024-03-11
00841982101831Reliance Fusion HeavyFH036362024-03-11
00841982101855Reliance Fusion HeavyFH040402024-03-11
00841982101879Reliance Fusion HeavyFH048482024-03-11
00841982101916Reliance Fusion HeavyFH054702024-03-11
00841982101527Reliance Fusion LightFL012122024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14