AccessGUDID - DEVICE: Rapid Seal Tube Sealer SE470 (08809241442233)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Seal Tube Sealer SE470
Version or Model: SE470
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SE470
Company Name: CENTRON CORPORATION

Primary DI Number: 08809241442233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557821760 *Terms of Use

Device Description: The Rapid Seal SE470 is a compact and lightweight tube sealer with a hand unit. The device is specially designed to seal the cord blood freezing bags and tubing. Long and slim sealing head is suitable for sealing the channels between two compartments of bag.

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?
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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 10.6 Centimeter
Height: 15.0 Centimeter
Depth: 26.0 Centimeter
Weight: 3.5 Kilogram

Device Record Status

Public Device Record Key: 8e252f93-2fd4-4f46-870e-018e962e790f
Public Version Date: July 07, 2020
Public Version Number: 2
DI Record Publish Date: April 03, 2020