AccessGUDID - DEVICE: Curaplex (00818834028042)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 301-0319LT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 301-0319LT
Company Name: TRI-ANIM HEALTH SERVICES, INC.

Primary DI Number: 00818834028042
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 010712461 *Terms of Use

Device Description: Adult High Concentration Procedural Oxygen Mask

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:	Yes
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?
35173	Non-rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	MASK, OXYGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 002be4d1-23d8-47b8-a4d9-2a1badcfc987
Public Version Date: January 14, 2021
Public Version Number: 2
DI Record Publish Date: July 01, 2019