AccessGUDID - DEVICE: Spacelabs Healthcare (10841522124839)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: TAY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 50-0034-08
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522124839
Issuing Agency: GS1
Commercial Distribution End Date: February 20, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: 4 ELECTRODE EVO RECORDER PACKED, BR PORTUGUESE

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:	Yes
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?
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWJ	Electrocardiograph, ambulatory (without analysis)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d8afcb7-ed54-4a24-adf6-33c4abdc354d
Public Version Date: March 18, 2025
Public Version Number: 5
DI Record Publish Date: August 20, 2018