FDA UDI
In Commercial Distribution
🇺🇸 United States
Direct Supply
DI: 18800003400574
·
Model: AVM-1
·
Mediana.CO.LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Direct Supply
- Primary DI
- 18800003400574
- Version / Model
- AVM-1
- Catalog Number
- PA3DS-PB0
- Company Name
- Mediana.CO.LTD
- Labeler DUNS
- 687879726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 6
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 8adea5d1-c65d-40d3-b924-020e8936f985
Device Description
The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult patients in all hospital areas, and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor | An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18800003400574 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051375 | 000 |