Pall

Primary DI
05034480315106
Brand
Pall
Company
Pall International Sàrl
Model
6254185
Catalog number
6254185
Device description
Transducer Protector Hydrophobic Vent Filter (female and male slip luer)
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K910821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910821000TRANSDUCER PROTECTORGelman Sciences, Inc.1991-08-12FIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480315107PackageGS150In Commercial Distribution
05034480315106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448031510735034480315107
05034480315106050344803151065034480315106

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system transducer protectorA device designed to protect a haemodialysis system pressure monitor from contamination 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 transfer of by viruses, bacteria, and particulate matter, while preventing the flow of fluids, to the pressure monitor. It may feature tubing and a male Luer lock designed to facilitate replacement of a contaminated transducer protector via a secondary connection on the pressure monitor. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Pore Size0.2Micrometer

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578EURegulatory@europe.pall.com

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05034480310125Pall PharmAssure® 25 mm Hydrophobic Vent FilterHP2002HP20022016-07-27
05034480000392Pall LeukoGuard LGLG6LG62015-10-21
05034480000408Pall LeukoGuard LGLG6BLG6B2015-10-21
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05034480104373Pall Supor® AEF FilterAEF1EAEF1E2016-07-20
05034480306104Pall LeukoGuard BC2BC2BBC2B2015-10-21
05034480308825Pall Supor® AEF FilterAEF1NTEAEF1NTE2016-07-20
05034480308979Pall LaparoShield® Plus Laparoscopic Smoke Filtration SystemLSF1LSF12016-07-20
05034480309143Pall® Pro-Tec Filter for Pulmonary Function TestingPF30SPF30S2016-07-20
05034480310170Pall PharmAssure® Syringe FilterHP4648HP46482024-03-15
05034480313553Pall-Aquasafe™ Water FilterAQF4AAQF4A2016-07-20
05034480313690Pall-Aquasafe™ Water FilterAQ31F1SAAQ31F1SA2016-07-20
05034480313744Pall-Aquasafe™ Water FilterAQ31F1RAAQ31F1RA2016-07-20
05034480313751Pall-Aquasafe™ Water FilterAQINAAQINA2016-07-20
05034480314147Pall LaparoShield® Plus Laparoscopic Smoke FilterLSF2LSF22016-07-20
05034480314802Pall-Aquasafe™ Detachable Shower RoseAQROSEAAQROSEA2016-07-20
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20
05034480315533Pall QPoint® Filter CapsuleQR22AQR22A2017-12-20

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Primary DI, Brand, Company table
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B144MPC85TE3Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2016-12-16
04054839076473Millex - FHMERCK MILLIPORE LIMITEDFIB2016-09-01
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04053252725180HydromillexMERCK MILLIPORE LIMITEDFIB2015-09-04
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorMEDISYSTEMS CORPORATIONFIB2015-09-01
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