FDA.reportPublic FDA data

ROMA Cordless handheld sealer for blood bag tubing

Primary DI
08033928530498
Brand
ROMA Cordless handheld sealer for blood bag tubing
Company
DELCON SRL
Model
HWONE.01
Device description
ROMA Cordless handheld sealer for blood bag tubing
Published
2023-07-25
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
08033928530498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928530498080339285304988033928530498

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
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
08033928530153HemoWeld-BHWELD-B.DB.002022-12-07
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
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