AccessGUDID - DEVICE: Yingtai (06976301910598)

GUDID

Device Identifier (DI) Information

Brand Name: Yingtai
Version or Model: ST9006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Changsha Yingtai Instrument Co., Ltd

Primary DI Number: 06976301910598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544727865 *Terms of Use

Device Description: Freeze dryer (lyophilizer) is an advanced vacuum freeze-drying device that uses low-temperature freezing and vacuum sublimation technology to directly convert the moisture in a sample into vapor for removal, achieving long-term preservation and quality optimization of materials. It is widely used in fields such as pharmaceuticals, biological products, food, chemicals, and laboratory research.

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?
43853	Laboratory freeze-dryer	A mains electricity (AC-powered) laboratory appliance designed to remove/extract all moisture (water content) from objects/materials placed within through the process of freeze-drying.	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: d973f5b0-87cf-4f1f-bd84-c7951d199147
Public Version Date: March 10, 2025
Public Version Number: 1
DI Record Publish Date: March 01, 2025