AccessGUDID - DEVICE: Meditech (05999056500044)

GUDID

Device Identifier (DI) Information

Brand Name: Meditech
Version or Model: ABPM-04 (BP4)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: -
Company Name: MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.

Primary DI Number: 05999056500044
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 401235817 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36888	Blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051149	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b30b8c3c-cdc0-4ea8-a1e3-76ae294f7a83
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: November 25, 2021