FDA UDI
In Commercial Distribution
🇺🇸 United States
Yingtai
DI: 06976301910352
·
Model: SI-II
·
Changsha Yingtai Instrument Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Yingtai
- Primary DI
- 06976301910352
- Version / Model
- SI-II
- Company Name
- Changsha Yingtai Instrument Co., Ltd
- Labeler DUNS
- 544727865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-01
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- 2c7081f8-cc4b-4732-b090-4fa6572c142d
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTQ | Bath, Incubators/Water, All | Microbiology | 866.2540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06976301910352 | GS1 |