AccessGUDID - DEVICE: ZOLL Arrhythmia Management System (00855778005357)

GUDID

Device Identifier (DI) Information

Brand Name: ZOLL Arrhythmia Management System
Version or Model: Sensor
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10A1087
Company Name: ZOLL MANUFACTURING CORPORATION

Primary DI Number: 00855778005357
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079320559 *Terms of Use

Device Description: No description.

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):	No
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?
65834	Wearable multiple vital physiological parameter monitoring system	A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DSI	Detector And Alarm, Arrhythmia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190939	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: 7d19235c-59fb-456c-9320-3c4dacbe4410
Public Version Date: April 02, 2025
Public Version Number: 3
DI Record Publish Date: October 21, 2020