FDA UDI
In Commercial Distribution
🇺🇸 United States
Med One
DI: 06953825908188
·
Model: UFR102
·
Shenzhen Urion Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Med One
- Primary DI
- 06953825908188
- Version / Model
- UFR102
- Company Name
- Shenzhen Urion Technology Co., Ltd
- Labeler DUNS
- 421294358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 03c2f016-4a68-4718-b292-d970378be45c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58391 | Medical device pressure monitor | A mechanical device designed to be connected to another device or system of devices (e.g., rectal suction biopsy system) to provide an accurate indication of the amount of negative pressure being applied in these devices during a surgical intervention or other procedure. It typically consists of a simple column that has incremented markings on its side(s) [e.g., in - cmH2O or - mmH2O], an indicator that shows the amount of negative pressure, and connectors for tubing that connect it to the operative device(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16953825908185 | GS1 | Carton | 60 | In Commercial Distribution | |
| Primary | 06953825908188 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200802 | 000 |