AccessGUDID - DEVICE: Sunset Heated CPAP Tube (00848530102753)

GUDID

Device Identifier (DI) Information

Brand Name: Sunset Heated CPAP Tube
Version or Model: TUB06HPR-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TUB06HPR-E
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530102753
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)

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?
12050	Heated respiratory humidifier	A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201418	000

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: 74240e3f-9212-42cb-9ccf-596e7c80dd28
Public Version Date: February 28, 2024
Public Version Number: 1
DI Record Publish Date: February 20, 2024