FDA.reportPublic FDA data

VSE4002XD - Empty Bag 600 mL

Primary DI
03567051503111
Brand
VSE4002XD - Empty Bag 600 mL
Company
MACO PHARMA
Model
VSE
Catalog number
VSE4002XD
Device description
600 mL Empty Bag.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
BK0300080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0300080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13567051503118PackageGS112Not in Commercial Distribution
03567051503111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1356705150311813567051503118
03567051503111035670515031113567051503111

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.

Contacts#

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

Regulatory Flags#

DUNS number
577149081
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03567051503227MacoMix HM20 and Hemolog 69HHM-020-F9HHM-020-F2018-07-30
03567050035347LCG2b with AS-1, AS-3 and AS-5KSVKSV0004XD2016-09-22
03567050052740VSE3010XD - Empty Bag 300 mL 6-Way ManVSEVSE3010XD2016-09-22
03567050069687VSE8004XD - Empty Bag 600 mL 6-Way ManVSEVSE8004XD2016-09-22
03567050069908VQE2001XD - 4 Empty Bags 300 mLVQEVQE2001XD2016-09-22
03567050070317VSL7001PD - Therapeutic Phlebotomy Bag w/NeedleVSLVSL7001PD2016-09-22
03567050070324VSL7000YD - Therapeutic Phlebotomy BagVSLVSL7000YD2016-09-22
03567051503128MRV6000LD - Therapeutic Phlebotomy Bag w/NeedleMRVMRV6000LD2016-09-22
03567050071970MacoSeal PS2-ASPS2-ASPS2-AS2022-12-31
03567050073097MACOSEAL LIGHT9MSLIGHT002024-08-27
035670515031669MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press9MPSBILAN9MPSBILAN2018-06-19
035670515031739MPSBIWIFI:MacoPress Smart and DMS WiFi Module-with breaker for main press9MPSBIWIFI9MPSBIWIFI2018-06-19
035670515031809MPSBRLAN:MacoPress Smart and DMS Ethernet Module-no breaker9MPSBRLAN9MPSBRLAN2018-06-19
035670515031979MPSBRWIFI-MacoPress Smart and DMS WiFi Module-no breaker9MPSBRWIFI9MPSBRWIFI2018-06-19
035670515032039MPSBR485: MacoPress Smart and DMS RS485 Module-no breaker9MPSBR4859MPSBR4852018-06-19
035670515032109MPSBI485:MacoPress Smart and DMS RS485 Module-with breaker for main press9MPSBI4859MPSBI4852018-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20810197810177GVSGvs Tm, Inc.CAK2026-01-19
04052682004308LeukoconnectFresenius Kabi AGCAK2022-06-02
14052682004305LeukoconnectFresenius Kabi AGCAK2022-06-02
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30887691000660HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
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10887691001243LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
10887691304214Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19
10887691305303HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691000752HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
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