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Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Midmark IQvitals is an affordable, Windows based device that provides automated blood pressure, temperature, SpO2 and pulse rate readings with a touch of the screen. Kit includes: IQvitals Device w/Blood Pressure, Temperature and SpO2, AC Power Supply, Reusable Blood Pressure Cuff - Adult, Reusable Blood Pressure Cuff - Large Adult, Blood Pressure Hose - 6.5', Reusable SpO2 Adult Finger Sensor, SpO2 Extender Cable - 4', Oral/Axillary Temperature Probe, Temperature Probe Covers (box of 20), Serial Cable - 10', and USB Cable - 10'. FDA UDI
- Model / Reference
- 4-000-0510 FDA UDI
- Description
- Midmark IQvitals is an affordable, Windows based device that provides automated blood pressure, temperature, SpO2 and pulse rate readings with a touch of the screen. Kit includes: IQvitals Device w/Blood Pressure, Temperature and SpO2, AC Power Supply, Reusable Blood Pressure Cuff - Adult, Reusable Blood Pressure Cuff - Large Adult, Blood Pressure Hose - 6.5', Reusable SpO2 Adult Finger Sensor, SpO2 Extender Cable - 4', Oral/Axillary Temperature Probe, Temperature Probe Covers (box of 20), Serial Cable - 10', and USB Cable - 10'. FDA UDI
Identifiers
- Catalog Number
- 4-000-0510 FDA UDI
- Primary DI / UDI-DI
- 00841709100819 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
Yes
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
Category: General-purpose multi-parameter bedside monitor
Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2 by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID
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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 |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA UDI 9b0a2ba7-4036-4be2-8b9d-12312dfeba51 36 fields · synced Jun 8, 2026