Millex - FH

Primary DI
04053252397837
Brand
Millex - FH
Company
MERCK MILLIPORE LIMITED
Model
SLFH1000N
Published
2015-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FIBProtector, Transducer, Dialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIBProtector, Transducer, DialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934069000MILLEX, DUALEX (PLUS, ULTRA)Millipore Corp.1994-04-21FIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252397837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252397837040532523978374053252397837

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system transducer protectorA sterile device designed to protect a haemodialysis system pressure monitor and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent cross-contamination by viruses, bacteria, and particulate matter while preventing the flow of fluids to the pressure monitor. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896873994
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436037123160Dualex Transducer ProtectorSLGVS25XS2015-09-04
04053252398018Dualex Plus Transducer ProtectorSLGVS25PS2015-09-01
04053252660283Dualex Ultra Transducer ProtectorSLGVS25US2015-09-04
04053252725180HydromillexSLST025DM2015-09-04
04054839076473Millex - FHSLFH1000N2016-09-01
04054839076565Dualex Plus Transducer ProtectorSLGVS25PS2016-09-01
04054839076572Dualex Ultra Transducer ProtectorSLGVS25US2016-09-01
04054839076756HydromillexSLST025DM2016-09-01
04054839078217Dualex Transducer ProtectorSLGVS25XS2016-09-01
04053252359194Multiscreen-HTS HVMSHVN45102023-10-13
04053252466274Multiscreen-HTS HVMSHVN45502023-10-13
04053252504501Multiscreen-HVMAHVN45102023-10-13
04053252505928Multiscreen-HVMAHVN45502023-10-13
04054839076251Millex-AASLAAM33SS2016-09-22
04054839076497Millex-GPSLGPM33RS2016-09-22
04054839076510Millex-GSSLGSM33SS2016-09-22
04054839076541Cathivex-GVSLGV0250S2016-09-22
04054839076558Millex-GVSLGVM33RS2016-09-22
04054839076596Millex-HASLHAM33SS2016-09-22
04054839076602Millex-HPSLHPM33RS2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082770036NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FIB2024-07-31
16948082770033NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FIB2024-07-31
B144MPC852Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2018-01-04
B144MPC853Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2018-01-04
B144MPC85TE2Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2016-12-16
B144MPC85TE3Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2016-12-16
04054839076473Millex - FHMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076565Dualex Plus Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076572Dualex Ultra Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076756HydromillexMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839078217Dualex Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
05034480315106PallPall International SàrlFIB2015-10-21
35034480315107PallPall International SàrlFIB2015-10-21
10840861100542FreseniusFresenius Medical Care Holdings, Inc.FIB2015-09-30
20840861100549FreseniusFresenius Medical Care Holdings, Inc.FIB2015-09-30
00383790004503NIPRO TP-SURENIPRO MEDICAL CORPORATIONFIB2015-09-16
10383790004500NIPRO TP-SURENIPRO MEDICAL CORPORATIONFIB2015-09-16
08436037123160Dualex Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-04
04053252660283Dualex Ultra Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-04
04053252725180HydromillexMERCK MILLIPORE LIMITEDFIB2015-09-04
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorMEDISYSTEMS CORPORATIONFIB2015-09-01
04053252398018Dualex Plus Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-01