AccessGUDID - DEVICE: Spacelabs Healthcare (10841522102721)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: 96280
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 040-0522-01
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522102721
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: KIT,DUAL-ANT,UHF,ACT,W/PS,INTL,ROHS

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?
36365	Electrocardiography monitoring system receiver	An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLD	MONITOR, ST SEGMENT WITH ALARM
MSX	SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
DSI	DETECTOR AND ALARM, ARRHYTHMIA
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141156	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
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c894b1a-d579-4a1e-9b8a-3b79f7535603
Public Version Date: November 28, 2022
Public Version Number: 12
DI Record Publish Date: December 22, 2016