AccessGUDID - DEVICE: Maxpert (00852359007380)

GUDID

Device Identifier (DI) Information

Brand Name: Maxpert
Version or Model: BCB2805
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXPERT MEDICAL

Primary DI Number: 00852359007380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066886996 *Terms of Use

Device Description: The Maxpert® Heavy Duty Fold Over Pill Crusher Pouch with Tear Top is a universal, disposable pill crusher pouch designed for use with pouch style pill crushers. Heavy duty multi-layer construction helps prevent this pouch from becoming punctured or bursting, which results in lost medication and time. The top of the pouch is designed to fold over; creating a closure that helps prevent emission of powder during the crushing process.

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:	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?
15750	Pill crusher/splitter	A hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	Container, Liquid Medication, Graduated

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: bec4d64b-1eae-4723-ad00-3f8c60cba8ef
Public Version Date: April 11, 2024
Public Version Number: 1
DI Record Publish Date: April 03, 2024