FDA.reportPublic FDA data

NA

Primary DI
00724995244392
Brand
NA
Company
STERIS CORPORATION
Model
enspire 3000 Maxflow Connector
Catalog number
ENLCS635
Device description
enspire 3000 MaxFlow Connector, ENLCS635
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, cleaning, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230930000
K243433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230930000enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation2023-06-30FEB
K243433000enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation2024-12-02FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995244392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995244392007249952443927249952443920724995244392

GMDN Terms#

Term, Definition table
TermDefinition
Luminal device flushing tubing set, reusableA collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
868205779
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995245962Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
00724995225223NASTERIS CORPORATIONFEB2024-06-03
00724995225230NASTERIS CORPORATIONFEB2024-06-03
00724995225247NASTERIS CORPORATIONFEB2024-06-03
00724995225254NASTERIS CORPORATIONFEB2024-06-03
00724995225261NASTERIS CORPORATIONFEB2024-06-03
00724995225278NASTERIS CORPORATIONFEB2024-06-03
00724995225285NASTERIS CORPORATIONFEB2024-06-03
00724995225292NASTERIS CORPORATIONFEB2024-06-03
00724995225308NASTERIS CORPORATIONFEB2024-06-03
00724995225315NASTERIS CORPORATIONFEB2024-06-03
00724995225322NASTERIS CORPORATIONFEB2024-06-03
00724995225339NASTERIS CORPORATIONFEB2024-06-03
00724995225346NASTERIS CORPORATIONFEB2024-06-03
00724995225353NASTERIS CORPORATIONFEB2024-06-03
00724995225360NASTERIS CORPORATIONFEB2024-06-03
00724995225377NASTERIS CORPORATIONFEB2024-06-03
00724995225384NASTERIS CORPORATIONFEB2024-06-03