AccessGUDID - DEVICE: Yingtai (06976301910482)

GUDID

Device Identifier (DI) Information

Brand Name: Yingtai
Version or Model: Iseal-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Changsha Yingtai Instrument Co., Ltd

Primary DI Number: 06976301910482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544727865 *Terms of Use

Device Description: Tube sealer is an industrial device that uses heat and pressure to securely seal materials such as plastic films, non-woven fabrics, or composite materials. It is widely used in fields such as food packaging, pharmaceutical product sealing, industrial manufacturing, and laboratory research. With its efficient operation and reliable sealing, it is an ideal choice for ensuring product integrity and extending storage life.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: afcae6f8-5922-408a-8669-a0dca2b1c0b7
Public Version Date: March 10, 2025
Public Version Number: 1
DI Record Publish Date: March 01, 2025