AccessGUDID - DEVICE: BodyGuardian (00852132007118)

GUDID

Device Identifier (DI) Information

Brand Name: BodyGuardian
Version or Model: EUBG2012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PREVENTICE TECHNOLOGIES, INC.

Primary DI Number: 00852132007118
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 859807815 *Terms of Use

Device Description: BodyGuardian Mini Biobank kit

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":	Yes
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?
31733	Electrocardiography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DSI	Detector And Alarm, Arrhythmia

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33c66094-ad84-409c-aa7c-9e35522cf82d
Public Version Date: June 17, 2021
Public Version Number: 2
DI Record Publish Date: August 07, 2019