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Meditech

FDA UDI

Class II (US FDA UDI)

by MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.

Identity

Trade Name
Meditech FDA UDI
Generic Name
Blood pressure ambulatory recorder FDA UDI
Device Name
The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring. FDA UDI
Model / Reference
ABPM-04 (BP4) FDA UDI
Description
The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring. FDA UDI

Identifiers

Catalog Number
- FDA UDI
Primary DI / UDI-DI
05999056500044 FDA UDI
510(k) Number
K051149 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Blood pressure ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Meditech by MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.

Sources (1)

  • FDA UDI b30b8c3c-cdc0-4ea8-a1e3-76ae294f7a83 36 fields · synced May 30, 2026