FDA UDI
In Commercial Distribution
🇺🇸 United States
Automatic High-throughput Exosome Extractor
DI: 06975064320002
·
Model: ZRM-C-AH-A
·
Zhaorui Medical (Shenzhen) Co., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Automatic High-throughput Exosome Extractor
- Primary DI
- 06975064320002
- Version / Model
- ZRM-C-AH-A
- Company Name
- Zhaorui Medical (Shenzhen) Co., LTD
- Labeler DUNS
- 601717757
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 1
- Public Version Date
- 2022-09-09
- Public Version Status
- New
- Public Device Record Key
- 37711114-1028-4604-9ef0-7e9e61b01f62
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 58386 | Centrifugal sample concentrator | A mains electricity (AC-powered) laboratory device designed to condense fluid clinical specimens (e.g., serum, urine, cerebrospinal fluid, ascites) using centrifugal rotation in order to harvest and preserve the particulate matter. Commonly known as a cyto-spin, it separates fluid from the solid particles, or cellular elements, of a specimen so they are more concentrated. It typically consists of a centrifuge with various rotor heads, microtitre plates, tubes, microscope slides, funnels and/or cups to which the sample is added, and absorptive material, filters, fluid collecting traps or a vacuum source utilized to separate and remove the liquid component. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975064320002 | GS1 |