FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional)
DI: 08885014410043
·
Model: T7100 Series
·
HEALTHSTATS INTERNATIONAL PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional)
- Primary DI
- 08885014410043
- Version / Model
- T7100 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
- 61582c46-b437-4627-9555-1e3b0fcb12dc
- Distribution End Date
- 2020-12-31
Device Description
The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure the Central Aortic Systolic Pressure (CASP) and additional arterial pulse waveform related indices based on arterial tonometry at the radial artery of the wrist.
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 | 08885014410043 | GS1 |
Customer Contacts
- Phone
- +6568583248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101002 | 000 |