AccessGUDID - DEVICE: CompoDock (04086000860215)

GUDID

Device Identifier (DI) Information

Brand Name: CompoDock
Version or Model: 9028721
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9028721
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000860215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.

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):	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 [?]
BK040076	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: 6acfbf22-f04b-43a2-9c26-b4ca67900e51
Public Version Date: September 03, 2018
Public Version Number: 4
DI Record Publish Date: September 16, 2016