FDA UDI
In Commercial Distribution
🇺🇸 United States
maguja
DI: 06951727601879
·
Model: CK-W118
·
Shenzhen Changkun Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- maguja
- Primary DI
- 06951727601879
- Version / Model
- CK-W118
- Company Name
- Shenzhen Changkun Technology Co., Ltd.
- Labeler DUNS
- 554502671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-14
- Public Version
- 1
- Public Version Date
- 2023-04-24
- Public Version Status
- New
- Public Device Record Key
- c869785c-2d78-466d-bbca-eea65256cd1d
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
- No
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31691 | Blood pressure alarm | An electronic device that receives signals from a blood pressure sensor and produces a sound and/or visual signal when pre-set upper or lower limits are exceeded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06951727601879 | GS1 | ||||
| Package | 16951727601883 | GS1 | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193386 | 000 |