Leukoconnect 4C4300

GUDID 14052682004305

LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution

Fresenius Kabi AG

Blood transfer set
Primary Device ID14052682004305
NIH Device Record Keyd39bbd14-5202-4037-b250-7c0952610f3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeukoconnect
Version Model Number4C4300
Catalog Number4C4300
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 Datefalse
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. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811137010486 [Previous]
GS104052682004308 [Primary]
GS114052682004305 [Package]
Contains: 04052682004308
Package: Carton [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAKMicrofilter, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-10
Device Publish Date2022-06-02

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Trademark Results [Leukoconnect]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEUKOCONNECT
LEUKOCONNECT
85226278 4012479 Live/Registered
Fenwal, Inc.
2011-01-26

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