PLASMALINK Bottle, 1000 mL with Locking Luer Adapt 6R2069

GUDID 04086000100342

For the collection, storage, and shipment of plasma prior to fractionation. Sterile Fluid Path.

Fresenius Kabi AG

Blood/tissue storage/culture container
Primary Device ID04086000100342
NIH Device Record Keya4fc6d9b-43fb-4088-bdb0-9b610e66de0a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLASMALINK Bottle, 1000 mL with Locking Luer Adapt
Version Model Number6R2069
Catalog Number6R2069
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000100342 [Primary]
GS114086000100349 [Package]
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-05

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