ALYX 2RBC-LR Kit with Saline Spike 4R5742

GUDID 14086000101032

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile fluid path.

Fresenius Kabi AG

Apheresis system tubing set
Primary Device ID14086000101032
NIH Device Record Key4f93cc64-694f-4bdb-90db-16d45b0ede0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameALYX 2RBC-LR Kit with Saline Spike
Version Model Number4R5742
Catalog Number4R5742
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 Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Controlled Room Temperature. Protect from Freezing. Avoid Excessive Heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811137012992 [Previous]
GS104086000101035 [Primary]
GS114086000101032 [Package]
Contains: 04086000101035
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-21
Device Publish Date2023-12-13

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