FDA UDI
In Commercial Distribution
🇺🇸 United States
LotFancy
DI: 06970384257793
·
Model: 11C-1880-H
·
HONSUN (NANTONG) CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LotFancy
- Primary DI
- 06970384257793
- Version / Model
- 11C-1880-H
- Company Name
- HONSUN (NANTONG) CO.,LTD
- Labeler DUNS
- 543364560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-16
- Public Version
- 5
- Public Version Date
- 2020-05-15
- Public Version Status
- Update
- Public Device Record Key
- 3922e1a4-6f07-4d20-9706-762044f68c0c
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
- No
- 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 |
|---|---|---|---|---|
| 16986 | Automatic-inflation electronic sphygmomanometer, portable, finger | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic finger-cuff inflation and measurement cycles. The cuff detects minute arterial volume changes in conjunction with an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial pressure. The device typically displays current heart rate in addition to systolic and diastolic blood pressures. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970384257790 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 06970384257793 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130925 | 000 |