AccessGUDID - DEVICE: Regard™ (30326053102784)

GUDID

Device Identifier (DI) Information

Brand Name: Regard™
Version or Model: 241028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 241028
Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Primary DI Number: 30326053102784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134472476 *Terms of Use

Device Description: Insufflation Tubing Set, 10ft, high flow, ULPA 0.1 micron filter swivel luer & swivel luer

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":	Yes
For Single-Use:	Yes
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?
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic

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: 4b4bd8f7-a7f4-4cf5-aedb-7dc588b2ca59
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023