NIPRO ELISIO™ -H HEMODIALYZER DD+ELISIO-13H

GUDID 40383790007083

Surface area 1.3m² Max.TMP:66kPa(500mmHg)

NIPRO MEDICAL CORPORATION

Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID40383790007083
NIH Device Record Key29677585-e200-48ef-b08e-c999c4181ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIPRO ELISIO™ -H HEMODIALYZER
Version Model NumberELISIO™-13H
Catalog NumberDD+ELISIO-13H
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100383790007085 [Primary]
GS140383790007083 [Package]
Contains: 00383790007085
Package: Case [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 Date2015-09-16

On-Brand Devices [NIPRO ELISIO™ -H HEMODIALYZER]

40383790007137Surface area 2.5m² Max.TMP:66kPa(500mmHg)
40383790007120Surface area 2.1m² Max.TMP:66kPa(500mmHg)
40383790007113Surface area 1.9m² Max.TMP:66kPa(500mmHg)
40383790007106Surface area 1.7m² Max.TMP:66kPa(500mmHg)
40383790007090Surface area 1.5m² Max.TMP:66kPa(500mmHg)
40383790007083Surface area 1.3m² Max.TMP:66kPa(500mmHg)
40383790007076Surface area 1.1m² Max.TMP:66kPa(500mmHg)
40383790007069Surface area 0.9m² Max.TMP:66kPa(500mmHg)

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