AccessGUDID - DEVICE: CARDINAL HEALTH (50885380159228)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 3124CV
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3124CV
Company Name: Cardinal Health 110, Inc.

Primary DI Number: 50885380159228
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2019
Device Count: 70
Labeler D-U-N-S® Number*: 063997360 *Terms of Use

Device Description: UNDERPAD EXTRA ABSORBENCY 24 X 36IN

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
Over the Counter (OTC):	Yes
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?
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	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: 9e949675-73c3-4bcf-8123-5e2d9016fa7e
Public Version Date: May 10, 2022
Public Version Number: 7
DI Record Publish Date: March 16, 2018