AccessGUDID - DEVICE: TCD B40 Wafers (10866305000223)

GUDID

Device Identifier (DI) Information

Brand Name: TCD B40 Wafers
Version or Model: TCD B40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 480-B40-00-1274
Company Name: GENESIS BPS LLC

Primary DI Number: 10866305000223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 240
Labeler D-U-N-S® Number*: 141091095 *Terms of Use

Device Description: The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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 [?]
BK950018	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 828d8e48-615f-4697-90ab-21a54eaf95ab
Public Version Date: November 06, 2019
Public Version Number: 1
DI Record Publish Date: October 29, 2019