FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MC3100™ Oscillometric Blood Pressure Monitor
DI: 08885014410029
·
Model: T3100 Series
·
HEALTHSTATS INTERNATIONAL PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MC3100™ Oscillometric Blood Pressure Monitor
- Primary DI
- 08885014410029
- Version / Model
- T3100 Series
- Company Name
- HEALTHSTATS INTERNATIONAL PTE LTD
- Labeler DUNS
- 628476459
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2022-10-06
- Public Version Status
- Update
- Public Device Record Key
- 6b27e3f4-93ee-4709-930e-1f2a4b7f6eed
- Distribution End Date
- 2020-12-31
Device Description
The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 36888 | Blood pressure ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08885014410029 | GS1 |
Customer Contacts
- Phone
- +6568583248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051546 | 000 |