AccessGUDID - DEVICE: Curaplex (00815277028264)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 021169-1S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 021169-1S
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00815277028264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Nasopharyngeal Airway Kit incl 6 Airways - 20 Fr - 24 Fr - 28 Fr- 30 Fr - 32 Fr and 34 Fr

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):	No
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?
36690	Cardiopulmonary resuscitation kit, reusable	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTQ	AIRWAY, NASOPHARYNGEAL

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: a2636e48-f5e0-4c9b-bed4-1cd0cf94763b
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: December 15, 2018