FDA UDI
In Commercial Distribution
🇺🇸 United States
Sample Processing kits for Blood Analysis (Canine)
DI: 06975679490244
·
Model: YH-HC501
·
Hunan Ehome Health Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sample Processing kits for Blood Analysis (Canine)
- Primary DI
- 06975679490244
- Version / Model
- YH-HC501
- Company Name
- Hunan Ehome Health Technology Co., Ltd.
- Labeler DUNS
- 550468087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-10
- Public Version
- 1
- Public Version Date
- 2025-10-20
- Public Version Status
- New
- Public Device Record Key
- f5c2b0b3-b036-44d6-8278-f5e0e1d15fb4
Device Description
Sample Processing kits for Blood Analysis (Canine),Each primary package of device count :20T
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52861 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975679490244 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat