AccessGUDID - DEVICE: Ultima Micro Nasal Cannula (B1400582S501)

GUDID

Device Identifier (DI) Information

Brand Name: Ultima Micro Nasal Cannula
Version or Model: 0582S-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0582S-50
Company Name: Braebon Medical Corporation

Primary DI Number: B1400582S501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Tubing used to detect airflow in sleep studies.

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):	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?
45566	Gas-sampling/monitoring respiratory tubing, single-use	A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	Cannula, Nasal, Oxygen

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: a73cdfa7-6008-48af-8534-7bb60e6c4627
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: October 25, 2019