AccessGUDID - DEVICE: ROMA Cordless handheld sealer for blood bag tubing (08033928530498)

GUDID

Device Identifier (DI) Information

Brand Name: ROMA Cordless handheld sealer for blood bag tubing
Version or Model: HWONE.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DELCON SRL

Primary DI Number: 08033928530498
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 440621212 *Terms of Use

Device Description: ROMA Cordless handheld sealer for blood bag tubing

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?
63858	Blood donor bag tube divider/sealer	An electrically-powered device designed to use heat to segment the plastic input tube of a blood donor bag, with automatic sealing of the ends of the divided segments. It may be used to create two or more segments, using heat to make a seal, after which the tube can be transected (e.g., for cross-testing sampling). It is typically used in blood donation centres and blood banks and is available in a variety of forms (e.g., hand-held, desktop); some types have barcode reading and labelling capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSD	Device, Heat-Sealing

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: fd209210-a049-4d13-97e0-98f4ce9cc101
Public Version Date: August 02, 2023
Public Version Number: 1
DI Record Publish Date: July 25, 2023