AccessGUDID - DEVICE: Curaplex (00810071633591)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 1071-10212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1071-10212
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00810071633591
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Emesis Bag, 1000cc, White, Cardboard Rim w/o Hand Protection 25/pk 10pk/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):	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?
36258	Emesis bag	A disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNY	BASIN, EMESIS

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: ce145ddf-cab4-40ad-a725-c6f038fc4ed0
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 2022