AccessGUDID - DEVICE: Catheter Stabilization Device (00801741076114)

GUDID

Device Identifier (DI) Information

Brand Name: Catheter Stabilization Device
Version or Model: FOL0102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FOL0102
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741076114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: StatLock 2-way Foley Stabilization Devices, Catheter Stabilization Devices, 2-way Foley Stabilitzation device. Includes: skin prep pad

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):	Yes
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?
57982	Urinary catheter holder	A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYJ	HOLDER, URETERAL CATHETER

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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ee87286-dc21-4f42-957e-2ff51f1c4174
Public Version Date: September 30, 2020
Public Version Number: 1
DI Record Publish Date: September 22, 2020