AccessGUDID - DEVICE: ProCure (10840330704615)

GUDID

Device Identifier (DI) Information

Brand Name: ProCure
Version or Model: 1006456
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1006456
Company Name: Twin Med, LLC

Primary DI Number: 10840330704615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107071289 *Terms of Use

Device Description: ProCure Oxygen Nasal Cannula Over the Ear Flared Nasal Tip Crush Resistant 21' Tubing Standard Connector Adult

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):	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?
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". 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: 21 Feet

Device Record Status

Public Device Record Key: d613e595-5717-4073-842a-bf829ea40fc0
Public Version Date: November 06, 2024
Public Version Number: 2
DI Record Publish Date: March 22, 2024