AccessGUDID - DEVICE: Yingtai (06976301910345)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 06976301910345
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544727865 *Terms of Use

Device Description: Incubator is a temperature-controlled device specifically designed for the cultivation and experimentation of biological samples. It is primarily used for the incubation and cultivation of cells, microorganisms, and biological specimens, and is widely applied in fields such as molecular biology, medical research, food testing, and biotechnology. The device provides an optimal growth environment for samples through precise temperature control and humidity regulation.

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?
64818	Microplate/tube/assay card incubator IVD	An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTQ	Bath, Incubators/Water, All

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: c400d7c4-8d3e-4482-be36-d6dad236b4d8
Public Version Date: March 10, 2025
Public Version Number: 1
DI Record Publish Date: March 01, 2025