AccessGUDID - DEVICE: Curaplex (00810071636400)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 2202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 287-2202
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00810071636400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: CURAPLEX OXYGEN MASK, PEDIATRIC, ELONGATED, HIGH CONC, TOTAL NRB, RESERVOIR BAG, 7 FT TUBING 50/CS

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?
35172	Aerosol face mask, non-rebreathing	A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGB	MASK, OXYGEN, NON-REBREATHING

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: f76f0413-23e6-45a2-b537-c4cb7fc1505b
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 2022