DEVICE: Genesis RapidWeld II STW Sterile Tube Welder (00866305000264)

Device Identifier (DI) Information

Genesis RapidWeld II STW Sterile Tube Welder
GRW-430-02
In Commercial Distribution
480-RW-2607-02
GENESIS BPS LLC
00866305000264
GS1

1
141091095 *Terms of Use
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62054 Laboratory tubing welder
A mains electricity (AC-powered) device intended to make a sterile connection (weld) between two segments of plastic tubing (typically blood transfer tubing during blood/blood component processing applications) in a clinical laboratory setting. It is a tabletop device which includes a blade, realignment mechanism, heating element and clamps intended to enable tubing dissection/reconnection while maintaining a closed system (sterile fluid path). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
KSB Set, Transfer (Blood/Plasma)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK210584 0
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Length: 33 Centimeter
Height: 9.9 Centimeter
Width: 14.2 Centimeter
Weight: 2.5 Kilogram
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Device Record Status

cf1858e9-2c43-4c09-ab92-8059559806b0
August 03, 2022
1
July 26, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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201-708-1400
info@genesisbps.com
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