AccessGUDID - DEVICE: Nasal Oxygen Cannula (00850014433154)

GUDID

Device Identifier (DI) Information

Brand Name: Nasal Oxygen Cannula
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU1010
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device Description: The nasal cannula is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.

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):	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?
46867	Oxygen administration enhancement device	A non-sterile device intended to be used to rapidly provide a supply of inhaled oxygen (O2) at higher than normal concentrations (e.g., FiO2 concentrations of 70% at 6L/min), typically for a patient during recovery [e.g., in the operating room (OR)]. It typically includes tubing that connects directly to an O2 source, a reservoir bag that concentrates the O2 and enables confirmation of respiration through its movement, a coupling that connects into an artificial airway already in situ, and a port for exhalation of gases. 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
Length: 7 Feet

Device Record Status

Public Device Record Key: d9b58f0e-2e0d-4eaa-89e6-29de24943ba5
Public Version Date: August 21, 2020
Public Version Number: 1
DI Record Publish Date: August 13, 2020