FDA UDI
In Commercial Distribution
🇺🇸 United States
VitalScan ANS
DI: 08690020003017
·
Model: HW10
·
Medeia, Inc.
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VitalScan ANS
- Primary DI
- 08690020003017
- Version / Model
- HW10
- Company Name
- Medeia, Inc.
- Labeler DUNS
- 031827187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-05
- Public Version
- 1
- Public Version Date
- 2025-02-13
- Public Version Status
- New
- Public Device Record Key
- 067a9589-2c0b-4260-8ab7-424824581862
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11413 | Electrocardiograph, professional, single-channel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included. | No | Active |
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside. | No | Active |
| 47582 | Pulse Co-oximeter probe, reusable | A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08690020003017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191266 | 000 |