FDA.reportPublic FDA data

HemoWeld-B

Primary DI
08033928530153
Brand
HemoWeld-B
Company
DELCON SRL
Model
HWELD-B.DB.00
Device description
Mobile tube sealer for medical PVC tubes
Published
2022-12-07
Public version status
New
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
08033928530153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928530153080339285301538033928530153

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
440621212
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
08033928530825MILANOHMIX4.31 Milano RFID version (white/grey)2024-01-10
08033928530832MILANOHMIX4.32 Milano standard version (white/grey)2024-01-10
08033928530016HemoMix 3HMIX3.4852022-12-07
08033928530023HemoMix 3HMIX3.485.RFID2022-12-07
08033928530061HemoMix 3HMIX3.WIFI.RFID2018-11-29
08033928530030HemoMix 3HMIX3.LAN2022-11-18
08033928530047HemoMix 3HMIX3.LAN.RFID2022-11-18
08033928530054HemoMix 3HMIX3.WIFI2022-11-18
08033928530580HemoMix 4HMIX4.21 RFID version (white/red shell)2022-11-17
08033928530597HemoMix 4HMIX4.22 standard version (white7red shell)2022-11-17
08033928530177HemoMix 4HMIX4.01 RFID version2020-03-12
08033928530184HemoMix 4HMIX4.02 standard version2020-03-12
08033928530498ROMA Cordless handheld sealer for blood bag tubingHWONE.012023-07-25
08033928530795ROMA ChargerACC0000662023-07-25
08033928530818HemoWeld-GunHWG2.002023-07-25
08033928530115HemoWeld-THWELD-T.DB.002022-12-07
08033928530122HemoWeld-GunHWG2.00H2022-12-07
08033928530139HemoWeld-GunHWG2.00V2022-12-07
08033928530146HemoWeld Gun HandgunHWG2.012022-12-07
08033928530160HemoWeld-SlimHWELDC.DB.002022-12-07

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
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
08033928530160HemoWeld-SlimDELCON SRLKSD2022-12-07
08033928530443WELD BDELCON SRLKSD2022-12-07