Identity
- Trade Name
- Direct Supply FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- AVM-1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- PA3DS-B0 FDA UDI
- Primary DI / UDI-DI
- 18800003400567 FDA UDI
- 510(k) Number
- K051375 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: General-purpose multi-parameter bedside monitor
Direct Supply by Mediana.CO.LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- SpO2 Adapter cable — Orantech Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
Cleared under the same submission
K051375 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mediana.CO.LTD
Sources (1)
- FDA UDI 0a8af805-c722-499f-bd8d-6e669705d392 35 fields · synced May 31, 2026