AccessGUDID - DEVICE: Curaplex (00810071633294)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: MS-001FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3271-60202
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00810071633294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Fitted Sheet, 30" x 72", Light Blue, 300lbs weight rating, Elastic Ends, 74gsm, 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":	No
For Single-Use:	No
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?
47456	Basic bed sheet, single-use	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	BEDDING, DISPOSABLE, MEDICAL

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: 6cc9f89e-053b-45dc-87f0-888700f1918d
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 2022