FDA.reportPublic FDA data

NIPRO TP-SURE

Primary DI
10383790004500
Brand
NIPRO TP-SURE
Company
NIPRO MEDICAL CORPORATION
Model
TPSURE+1
Device description
TRANSDUCER PROTECTOR
Published
2015-09-16
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383790004500PackageGS1100In Commercial Distribution
40383790004501PackageGS110In Commercial Distribution
00383790004503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038379000450010383790004500
4038379000450140383790004501
00383790004503003837900045033837900045030383790004503

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
797372554
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
false
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
00383790011839PRESSONETRG001-000-000-0012026-05-01
00383790012478relasyringe SYPR-03GA-WPSYPR-03GA-WP6; SYPR-03GA-WP602026-05-01
00383790012515relasyringe SYPR-03GA-WP-S-USSYPR-03GA-WP6-S-US; SYPR-03GA-WP60-S-US2026-05-01
00383790008037Nipro SafeTouch NeedleSAH+1825-1M2026-04-30
00383790008105Nipro SafeTouch NeedleSAH+2138-1M2026-04-30
00383790008136Nipro SafeTouch NeedleSAH+2238-1M2026-04-30
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
40383790012377Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
40383790012384Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
40383790012391Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
40383790012407Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
40383790012414Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
00383790004503NIPRO TP-SURETPSURE+12015-09-16
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A226Y/V813-NIJ2025-06-01
00383790011884NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A217Y/V806-NIJ2025-06-01
00383790011891NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A209Y/V803-NIJ2025-06-01

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
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