AccessGUDID - DEVICE: Transcend (M9505030640)

GUDID

Device Identifier (DI) Information

Brand Name: Transcend
Version or Model: Heated Humidifier
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 503064
Company Name: SOMNETICS INTERNATIONAL, INC.

Primary DI Number: M9505030640
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047069263 *Terms of Use

Device Description: No description.

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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131388	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
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 6.625 Inch
Length: 12.25 Inch
Height: 5.1875 Inch

Device Record Status

Public Device Record Key: faa18569-a201-438a-98d0-5e5587a3cef7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016