FX CorAL 120 Dialyzer

GUDID 10840861102669

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID10840861102669
NIH Device Record Key07948ed4-f1ae-46f9-9b0b-0e6ffe7f9d25
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX CorAL 120 Dialyzer
Version Model NumberF00009219
Company DUNS958291411
Company NameFresenius Medical Care Holdings, Inc.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter
Area/Surface Area2.5 Square meter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861102662 [Primary]
GS110840861102669 [Package]
Contains: 00840861102662
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-23

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

10840861102638 - FX CorAL 60 Dialyzer2024-03-04
10840861102652 - FX CorAL 100 Dialyzer2024-03-04
10840861102669 - FX CorAL 120 Dialyzer2024-03-04
10840861102669 - FX CorAL 120 Dialyzer2024-03-04
10840861102676 - FX CorAL 600 Dialyzer2024-03-04
10840861102683 - FX CorAL 800 Dialyzer2024-03-04
10840861102690 - FX CorAL 1000 Dialyzer2024-03-04
10840861102409 - CombiSet2023-10-27
10840861102645 - FX CorAL 80 Dialyzer2023-10-12

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