FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A-PULSE CASP® Pulse Wave Analysis System
DI: 08885014410036
·
Model: T6400 Series
·
HEALTHSTATS INTERNATIONAL PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A-PULSE CASP® Pulse Wave Analysis System
- Primary DI
- 08885014410036
- Version / Model
- T6400 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
- 90f0965c-fe1b-4a9e-9bf6-1380f0cdf37f
- Distribution End Date
- 2020-12-31
Device Description
The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the A-PULSE CASP® pulse wave application software. The BPro® device is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 | 08885014410036 | GS1 |
Customer Contacts
- Phone
- +6568583248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072593 | 000 |