NIPRO Cellentia™-H Hemodialyzer DD+CT21H

GUDID 40383790004419

CELLULOSE TRIACETATE HEMODIALYZER 2.1m² / Max.TMP 66kPa (500mmHg)

NIPRO MEDICAL CORPORATION

Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID40383790004419
NIH Device Record Key44f7b82d-c1b5-4dcb-8c1a-01d4726fd212
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIPRO Cellentia™-H Hemodialyzer
Version Model NumberCellentia™-21H
Catalog NumberDD+CT21H
Company DUNS797372554
Company NameNIPRO MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100383790004411 [Primary]
GS140383790004419 [Package]
Contains: 00383790004411
Package: [24 Units]
In Commercial Distribution

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-06-15

On-Brand Devices [NIPRO Cellentia™-H Hemodialyzer]

40383790004419CELLULOSE TRIACETATE HEMODIALYZER 2.1m² / Max.TMP 66kPa (500mmHg)
40383790004402CELLULOSE TRIACETATE HEMODIALYZER 1.9m² / Max.TMP 66kPa (500mmHg)
40383790004396CELLULOSE TRIACETATE HEMODIALYZER 1.7m² / Max.TMP 66kPa (500mmHg)
40383790004389CELLULOSE TRIACETATE HEMODIALYZER 1.5m² / Max.TMP 66kPa (500mmHg)

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