FDA.reportPublic FDA data

MacoSeal PS2-AS

Primary DI
03567050071970
Brand
MacoSeal PS2-AS
Company
MACO PHARMA
Model
PS2-AS
Catalog number
PS2-AS
Device description
The MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It performs pre-cut welding on wet or dry tube using high frequency. The MacoSeal PS2-AS can be used either in fixed collection or in mobile collection or preparation site.
Published
2022-12-31
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
03567050071970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03567050071970035670500719703567050071970

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius60 Degrees Celsius

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
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
06976301910840YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910857YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910864YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910871YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910420YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
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
03567050073097MACOSEAL LIGHTMACO PHARMAKSD2024-08-27
08033928530498ROMA Cordless handheld sealer for blood bag tubingDELCON SRLKSD2023-07-25
08033928530795ROMA ChargerDELCON SRLKSD2023-07-25
08033928530818HemoWeld-GunDELCON SRLKSD2023-07-25
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