AccessGUDID - DEVICE: RHYTHMIA HDx™ (00191506020804)

GUDID

Device Identifier (DI) Information

Brand Name: RHYTHMIA HDx™
Version or Model: M004RA65010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004RA65010
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506020804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Ablation Connection Box (for INTELLAGEN™)

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?
46265	Cardiac mapping system	An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020025	141
P150005	079
P920047	133

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: 9e3427c2-7f87-4e30-b72c-84d6c73516e6
Public Version Date: September 11, 2024
Public Version Number: 1
DI Record Publish Date: September 03, 2024