FDA.reportPublic FDA data

MRV6000LD - Therapeutic Phlebotomy Bag w/Needle

Primary DI
03567051503128
Brand
MRV6000LD - Therapeutic Phlebotomy Bag w/Needle
Company
MACO PHARMA
Model
MRV
Catalog number
MRV6000LD
Device description
500 mL Phlebotomy Bag with Needle.
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
13567051503125PackageGS120Not in Commercial Distribution
03567051503128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1356705150312513567051503125
03567051503128035670515031283567051503128

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, triple-packAn assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells and plasma. It includes three containers (flexible bags) ? one or more with anticoagulation solution and/or preservatives for red blood cells, 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 red blood cells and plasma are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers 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
03567051503111VSE4002XD - Empty Bag 600 mLVSEVSE4002XD2016-09-22
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

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Primary DI, Brand, Company table
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