NovaLine

Primary DI
16948082770033
Brand
NovaLine
Company
Bain Medical Equipment (Guangzhou) Co., Ltd.
Model
956007
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
K240164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240164000NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.2024-06-28FIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948082770033PackageGS160In Commercial Distribution
26948082770030PackageGS110In Commercial Distribution
06948082770036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694808277003316948082770033
2694808277003026948082770030
06948082770036069480827700366948082770036

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
526972767
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06948082700729DORABAIN-BL-002E2026-05-13
06948082753947DORABAIN-A.V.F-001ASE2026-05-13
06948082753954DORABAIN-A.V.F-001VSE2026-05-13
06948082770036NovaLine9560072024-07-31
06948082746086DORABAIN-A.V.F-001SE2023-04-11
06948082746093DORABAIN-A.V.F-005SE2023-04-11
06948082746116DORABAIN-A.V.F-049SE2023-04-11
06948082749681DORABAIN-A.V.F-003SE2023-04-11
06948082749698DORABAIN-A.V.F-007SE2023-04-11
06948082749704DORABAIN-A.V.F-051SE2023-04-11
16948082746083DORABAIN-A.V.F-001SE2023-04-11
16948082746090DORABAIN-A.V.F-005SE2023-04-11
06948082746109DORABAIN-A.V.F-009SE2023-04-11
16948082746113DORABAIN-A.V.F-049SE2023-04-11
16948082749688DORABAIN-A.V.F-003SE2023-04-11
16948082749695DORABAIN-A.V.F-007SE2023-04-11
16948082749701DORABAIN-A.V.F-051SE2023-04-11
06948082746642DORABAIN-A.V.F-011SE2022-12-28
06948082746659DORABAIN-A.V.F-012SE2022-12-28
06948082709777NovaLineBL 422022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082770036NovaLineBain 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
04053252397837Millex - FHMERCK 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