AccessGUDID - DEVICE: Bard® CritiCore® Face Shield (00801741137525)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® CritiCore® Face Shield
Version or Model: 000002FS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000002FS
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741137525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® CritiCore® Face Shield

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):	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?
47458	Urine monitoring system	An assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXS	URINOMETER, ELECTRICAL

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: ad3c7b67-76b8-40c8-ba38-712e8042039a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2017