LCG2b with AS-1, AS-3 and AS-5 KSV0004XD

GUDID 13567050035344

Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.

MACO PRODUCTIONS

Blood donor set, single-pack
Primary Device ID13567050035344
NIH Device Record Key7294307a-0a17-4ad9-94e8-b3442db6bf8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLCG2b with AS-1, AS-3 and AS-5
Version Model NumberKSV
Catalog NumberKSV0004XD
Company DUNS265492868
Company NameMACO PRODUCTIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com
Phone770-270-6867
EmailCustomerCare@MacopharmaUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103567050035347 [Primary]
GS113567050035344 [Package]
Contains: 03567050035347
Package: Carton [15 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-02-12
Device Publish Date2016-09-22

Devices Manufactured by MACO PRODUCTIONS

13567050035344 - LCG2b with AS-1, AS-3 and AS-52025-02-12Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
13567050035344 - LCG2b with AS-1, AS-3 and AS-52025-02-12 Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber,
13567050052747 - VSE3010XD - Empty Bag 300 mL 6-Way Man2025-02-12 300 mL Empty Bag for Pooling of Blood Components.
13567050069684 - VSE8004XD - Empty Bag 600 mL 6-Way Man2025-02-12 600 mL Empty Bag for Pooling of Blood Components.
13567050069905 - VQE2001XD - 4 Empty Bags 300 mL2025-02-12 300ml Quad Splitting Empty Bags.
13567050070314 - VSL7001PD - Therapeutic Phlebotomy Bag w/Needle2025-02-12 600 mL Phlebotomy Bag with Needle.
13567050070321 - VSL7000YD - Therapeutic Phlebotomy Bag2025-02-12 600 mL Phlebotomy Bag with Luer Lock.
03567050071970 - MacoSeal PS2-AS2025-02-12 The MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It p
03567051503227 - MacoMix HM20 and Hemolog 62025-02-12 The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the

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