AccessGUDID - DEVICE: Bard Stoma Measuring Device (00801741081149)

GUDID

Device Identifier (DI) Information

Brand Name: Bard Stoma Measuring Device
Version or Model: 000842
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000842
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741081149
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Bard Stoma Measuring Device 18F/24F

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):	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?
63943	Stomal diameter sizer	A device intended to be used to measure the diameter of a stomal opening at the body surface to help in the selection of an appropriately-sized stomal appliance (e.g., ostomy bag). It is typically in the form of a paper/plastic sheet with holes of graduated sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Catheter Gauge: 24 French
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: 6d242878-95d5-4402-8473-bc28610fec42
Public Version Date: April 17, 2024
Public Version Number: 5
DI Record Publish Date: February 18, 2016