TPE Plasma Exchange Set 9400451

GUDID 04086000901550

Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma exchange, red blood cell exchange).

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID04086000901550
NIH Device Record Key574d3266-5468-4759-95a6-a99527552009
Commercial Distribution StatusIn Commercial Distribution
Brand NameTPE Plasma Exchange Set
Version Model Number9400451
Catalog Number9400451
Company DUNS315654579
Company NameFresenius Kabi AG
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000901543 [Primary]
GS104086000901550 [Package]
Contains: 04086000901543
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-03
Device Publish Date2016-09-16

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