AccessGUDID - DEVICE: Celon Wet Bands 66 x 120mm (00848530101824)

GUDID

Device Identifier (DI) Information

Brand Name: Celon Wet Bands 66 x 120mm
Version or Model: WB66120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530101824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1500
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Celon Wets Bands 66x120mm

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:	Yes
Prescription Use (Rx):	No
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?
61365	Medical gas flowmeter, Thorpe tube	A device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated

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: 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: ac352366-a11c-4c27-9c60-271c6b1c4a91
Public Version Date: March 28, 2024
Public Version Number: 1
DI Record Publish Date: March 20, 2024