AccessGUDID - DEVICE: Total Containment Device (TCD) (00866305000219)

GUDID

Device Identifier (DI) Information

Brand Name: Total Containment Device (TCD)
Version or Model: TCD B40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 480-B40-00-1245
Company Name: GENESIS BPS LLC

Primary DI Number: 00866305000219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141091095 *Terms of Use

Device Description: The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1.6 Kilogram
Width: 9.1 Centimeter
Length: 27.2 Centimeter
Height: 5.9 Centimeter

Device Record Status

Public Device Record Key: a0436408-9c69-4050-87ba-534d3cc853fb
Public Version Date: October 29, 2019
Public Version Number: 4
DI Record Publish Date: August 02, 2016