FDA.reportPublic FDA data

SteriCUBE Filter Kit +

Primary DI
00851489007222
Brand
SteriCUBE Filter Kit +
Company
Stericube, LLC
Model
SteriCUBE-PACK-025-FCSKIT
Catalog number
MTS-25-FCSKIT
Device description
Filter Kit - 25 Cycles, including Filters, Indicator Locks, and Filter Separator
Published
2024-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152014000MTS300 Multiple Tray Sterilization SystemPmbs, LLC2015-10-20KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851489007222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851489007222008514890072228514890072220851489007222

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container filter, single-useA device designed to function as a microbial barrier in containers used for steam or solvent sterilization. It allows penetration of the sterilization agent as it prevents the passage of microorganisms. It is typically made of a thin, porous, non-woven fabric material or paper. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
908-300-7093mem.pmbs@gmail.com
8334112823info@stericubeinc.com

Regulatory Flags#

DUNS number
079665067
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851489007215MTS225 TCFL Transfer CartMTS-225-TC-TCFLMTS-225-TC2020-06-01
00851489007055MTS300 Cabinet,MTS300 Cabinet SteriCUBE-300-CAB2016-12-09
00851489007109MTS300 Transfer CartMTS300 Transfer CartSteriCUBE-300-CART2017-01-24
00851489007253SteriCUBECERAMIC DISC KIT031001-002026-01-06
00851489007239SteriCUBE 225 Cabinet, STERIS 600MTS225-STR-1 CABSteriCUBE-CBNT-225-ST06002024-01-22
00851489007246SteriCUBE 225 Transfer Cart, STERIS 600MTS225-STR-1 TCSteriCUBE-CART-225-ST06002024-01-22
00851489007185MTS225 STERIS Transfer CartMTS-225-TC-STR-1MTS-225-TC-STR-12020-06-01
00851489007192MTS225 GETINGE CabinetMTS-225-CAB-GET-1MTS-225-CAB-GET-12020-06-01
00851489007208MTS225 GETINGE Transfer CartMTS-225-TC-GET-1MTS-225-TC-GET-12020-06-01
00851489007000MTS300 Filter KitMTS300-FiltersMTS-Filters2016-12-09
00851489007024MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-0MTS300 Transfer Cart STR-02016-12-09
00851489007031MTS300 Cabinet, Steris, StandardMTS300 Cabinet STR-1RMTS300 Cabinet STR-1R2016-12-09
00851489007048MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-1RMTS300 Transfer Cart STR-1R2016-12-09
00851489007062MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-1MTS300 Transfer Cart STR-12016-12-09
00851489007079MTS300 Cabinet, Steris, EvolutionMTS300 Cabinet STR-2SteriCUBE-CBNT-300-STEVOL2016-12-09
00851489007086MTS300 Transfer Cart, Steris, EvolutionMTS300 Transfer Cart STR-2SteriCUBE-CART-300-STEVOL2016-12-09
00851489007093MTS300 Floor Loader, GetingeMTS300 Floor Loader GET-FLMTS300 Floor Loader GET-FL2017-01-24
00851489007116MTS300 Transfer Cart, GetingeMTS300 Transfer Cart, GET-1MTS300 Transfer Cart, GET-12017-01-24
00851489007123MTS300 Cabinet, GetingeMTS300 Cabinet GET-1MTS300 Cabinet GET-12017-07-25
00851489007147STERIS BridgeMTS-BR-STRMTS-BR-STR2020-06-01

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