AccessGUDID - DEVICE: Fenwal Hand Sealer (00810020441062)

GUDID

Device Identifier (DI) Information

Brand Name: Fenwal Hand Sealer
Version or Model: 4R4454W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4R4454W
Company Name: Fresenius Kabi AG

Primary DI Number: 00810020441062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418.

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
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e4748e37-3d05-4ca9-8152-b7d0dc49d14e
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025