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

Primary DI
13567050035344
Brand
LCG2b with AS-1, AS-3 and AS-5
Company
MACO PRODUCTIONS
Model
KSV
Catalog number
KSV0004XD
Device description
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.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAKMicrofilter, Blood Transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAKMicrofilter, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1200710

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200710

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13567050035344PackageGS115In Commercial Distribution
03567050035347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1356705003534413567050035344
03567050035347035670500353473567050035347

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, single-packAn assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-270-6867CustomerCare@MacopharmaUSA.com

Regulatory Flags#

DUNS number
265492868
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13567050052747VSE3010XD - Empty Bag 300 mL 6-Way ManVSEVSE3010XD2016-09-22
13567050069684VSE8004XD - Empty Bag 600 mL 6-Way ManVSEVSE8004XD2016-09-22
13567050069905VQE2001XD - 4 Empty Bags 300 mLVQEVQE2001XD2016-09-22
13567050070314VSL7001PD - Therapeutic Phlebotomy Bag w/NeedleVSLVSL7001PD2016-09-22
13567050070321VSL7000YD - Therapeutic Phlebotomy BagVSLVSL7000YD2016-09-22
13567051503118VSE4002XD - Empty Bag 600 mLVSEVSE4002XD2016-09-22
13567051503125MRV6000LD - Therapeutic Phlebotomy Bag w/NeedleMRVMRV6000LD2016-09-22

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