FDA.reportPublic FDA data

Rapid Seal Tube Sealer SE340

Primary DI
08809241443124
Brand
Rapid Seal Tube Sealer SE340
Company
CENTRON CORPORATION
Model
SE340
Catalog number
SE340
Device description
The Rapid Seal SE340 is a multiple station bench-top tube sealer with fixed sealing head and hand-held sealing unit. When blood bag tubing is placed in the sealing head, tubing melts in about one second and then cools to form a seal. At hand sealing unit, pulling trigger lever starts sealing process. After tubing melts and a seal is formed, indication lamp turns off.
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08809241443124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809241443124088092414431248809241443124

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. It is typically used in blood donation centres and blood banks and is available in a variety of forms (e.g., hand-held, desktop).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth33.1Centimeter
Height15.6Centimeter
Weight5Kilogram
Width17.6Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557821760
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
08809241446224Blood Collection Monitor CM350CM350CM3502020-04-17
08809241446132Blood Collection Mixer CM735ACM735ACM735A2020-04-03
08809241446446Data Collection Mixer DCM3000 (BASIC)DCM3000BCM7602020-04-03
08809241443520MacoSeal SE160SE160SE1602020-04-03
08809241441328Rapid Seal Tube Sealer SE530SE530SE5302020-04-03
08809241442233Rapid Seal Tube Sealer SE470SE470SE4702020-04-03
08809241443223Rapid Seal Tube Sealer SE540SE540SE5402020-04-03
08809241444527Rapid Seal Tube Sealer SE640SE640SE6402020-04-03
08809241441229Rapid Seal Tube Sealer SE330SE330SE3302020-04-02

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
08033928530153HemoWeld-BDELCON SRLKSD2022-12-07
08033928530160HemoWeld-SlimDELCON SRLKSD2022-12-07