AccessGUDID - DEVICE: Regard™ (10326053106931)

GUDID

Device Identifier (DI) Information

Brand Name: Regard™
Version or Model: HT0454
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Primary DI Number: 10326053106931
Issuing Agency: GS1
Commercial Distribution End Date: August 25, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 945020902 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
46362	Fluid/device delivery cardiac catheter	A sterile, steerable, flexible tube containing electrodes intended to be introduced percutaneously into the heart chambers in order to provide a pathway for the controlled delivery and support of a selective infusion of fluids or transvenous devices to the heart (e.g., the coronary sinus) and coronary vasculature. It may also be used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite and have an actuator mechanism located at the proximal end used to steer the tip in the desired direction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OES	Cardiac Catheterization Kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 74a2af97-fb07-4b30-9a5c-627a59432689
Public Version Date: August 26, 2020
Public Version Number: 3
DI Record Publish Date: November 30, 2016