FDA UDI
In Commercial Distribution
🇺🇸 United States
SphygmoCor
DI: 19351315000031
·
Model: XCEL
·
ATCOR MEDICAL PTY LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SphygmoCor
- Primary DI
- 19351315000031
- Version / Model
- XCEL
- Company Name
- ATCOR MEDICAL PTY LTD
- Labeler DUNS
- 751626706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1b7eaf99-cf02-426d-8833-6c9a77536c48
Device Description
Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others). CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL: • XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only]. • XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)].
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DSK | Computer, Blood-Pressure | Cardiovascular | 870.1110 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36553 | Patient monitoring system module, multifunction | A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 19351315000031 | GS1 | ||||
| Direct Marking | 19351315000048 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122129 | 000 |