FDA.reportPublic FDA data

NIPRO Cellentia™-H Hemodialyzer

Primary DI
00383790004398
Brand
NIPRO Cellentia™-H Hemodialyzer
Company
NIPRO MEDICAL CORPORATION
Model
Cellentia™-17H
Catalog number
DD+CT17H
Device description
CELLULOSE TRIACETATE HEMODIALYZER1.7m² / Max.TMP 66kPa (500mmHg)
Published
2017-06-15
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
KDIDialyzer, high permeability with or without sealed dialysate system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40383790004396PackageGS124In Commercial Distribution
00383790004398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4038379000439640383790004396
00383790004398003837900043983837900043980383790004398

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, single-useA filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(908) 393-7030info@nipromed.com

Regulatory Flags#

DUNS number
797372554
Device count
1
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
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08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
04039361259150FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259570FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259594FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259617FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259631FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259655FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259938FX CorALFresenius Medical Care AGKDI2026-01-02
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
04987671041708Hemodialysis Delivery SystemNIKKISO CO.,LTD.KDI2025-08-22
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