AccessGUDID - DEVICE: Rhythmia™ Mapping System (08714729841975)

GUDID

Device Identifier (DI) Information

Brand Name: Rhythmia™ Mapping System
Version or Model: M004RH10000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729841975
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Signal Station Kit

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?
46250	Transducer signal amplifier	An electronic device that increases current, voltage, or power to intensify the electrical signal sent to or received from a transducer (e.g., electroacoustic, electro-optical, electromechanical), sometimes providing impedance matching. It will provide an electrical interface between a physiological transducer and a patient monitor or patient monitoring system that is used to monitor pressures such as, noninvasive and invasive blood pressure, oesophageal pressures, urinary tract pressures, intrauterine pressures and intraocular pressures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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: f693d207-dedb-4b04-8736-278d0ca9b2db
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016