P1R Plasma Treatment Set 9400414

GUDID 04052682003721

Therapeutic Plasma Treatment (e.g. LDL-apheresis)

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID04052682003721
NIH Device Record Key1c085a0e-f1fe-4721-b0d4-8223ecfbc3de
Commercial Distribution StatusIn Commercial Distribution
Brand NameP1R Plasma Treatment Set
Version Model Number9400414
Catalog Number9400414
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
GS104052682003721 [Primary]
GS104052682003738 [Package]
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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