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

GUDID

Device Identifier (DI) Information

Brand Name: Genesis RapidWeld II STW Sterile Tube Welder
Version or Model: GRW-430-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 480-RW-2607-02
Company Name: GENESIS BPS LLC

Primary DI Number: 00866305000264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141091095 *Terms of Use

Device Description: 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).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: cf1858e9-2c43-4c09-ab92-8059559806b0
Public Version Date: August 03, 2022
Public Version Number: 1
DI Record Publish Date: July 26, 2022