AccessGUDID - DEVICE: seca mVSA 535 (04012030019095)

GUDID

Device Identifier (DI) Information

Brand Name: seca mVSA 535
Version or Model: 535
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5351200131
Company Name: seca GmbH & Co. KG

Primary DI Number: 04012030019095
Issuing Agency: GS1
Commercial Distribution End Date: December 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 316584937 *Terms of Use

Device Description: Spot-check-monitor inclusive blood pressure and Masimo Spo2 module.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
57960	Multiple physiological parameter spot-check system, clinical	An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter
DXN	System, measurement, blood-pressure, non-invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192092	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: 1b99957e-66c6-4d1d-834f-63cd5ff124ac
Public Version Date: January 07, 2025
Public Version Number: 5
DI Record Publish Date: February 28, 2020