FDA.reportPublic FDA data

MACOSEAL LIGHT

Primary DI
03567050073097
Brand
MACOSEAL LIGHT
Company
MACO PHARMA
Model
9MSLIGHT00
Device description
MacoSeal LIGHT is a cordless, automatic, and portable tube sealer, designed for sealing tubing of blood bags systems. This sealer can be used in both fixed and mobile collection sites, as well as in preparation sites, to hermetically seal PVC tubing in an automatic operation that ensures the reproducible quality, width and separation of sealings. It is composed of three (3) mobile parts sold together, not separately.
Published
2024-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KSDDevice, Heat-Sealing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSDDevice, Heat-SealingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03567050073097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03567050073097035670500730973567050073097

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor bag tube divider/sealerAn electrically-powered device designed to use heat to segment the plastic input tube of a blood donor bag, with automatic sealing of the ends of the divided segments. It may be used to create two or more segments, using heat to make a seal, after which the tube can be transected (e.g., for cross-testing sampling). It is typically used in blood donation centres and blood banks and is available in a variety of forms (e.g., hand-held, desktop); some types have barcode reading and labelling capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
577149081
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
03567051503128MRV6000LD - Therapeutic Phlebotomy Bag w/NeedleMRVMRV6000LD2016-09-22
03567050071970MacoSeal PS2-ASPS2-ASPS2-AS2022-12-31
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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06976301910437YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910444YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910451YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910468YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910475YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910482YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910499YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910505YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910512YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910529YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910536YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910543YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910550YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910567YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
08033928530498ROMA Cordless handheld sealer for blood bag tubingDELCON SRLKSD2023-07-25
08033928530795ROMA ChargerDELCON SRLKSD2023-07-25
08033928530818HemoWeld-GunDELCON SRLKSD2023-07-25
03567050071970MacoSeal PS2-ASMACO PHARMAKSD2022-12-31
08033928530115HemoWeld-TDELCON SRLKSD2022-12-07
08033928530122HemoWeld-GunDELCON SRLKSD2022-12-07
08033928530139HemoWeld-GunDELCON SRLKSD2022-12-07
08033928530146HemoWeld Gun HandgunDELCON SRLKSD2022-12-07
08033928530153HemoWeld-BDELCON SRLKSD2022-12-07
08033928530160HemoWeld-SlimDELCON SRLKSD2022-12-07
08033928530443WELD BDELCON SRLKSD2022-12-07