AccessGUDID - DEVICE: CARDINAL HEALTH (10885380100321)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: LJ33121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LJ33121
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380100321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Cardinal Health Lubricating Jelly Net Wt 2oz -Bacteriostatic -CHG-Free -Water-soluble -Greaseless -Unscented Sterile Product is sterile unless package is damaged or opened. Do not re-sterilize. Not Made with Natural Rubber Latex. To open aseptically, sanitize tube tip and cap with a topical antiseptic, such as an alcohol wipe, prior to opening. Remove cap and peel o_ seal. Replace cap. Lubricating jelly is water soluble, stable, non-greasy and spreads evenly. It is ideal for lubricating rubber products, such as catheters and rectal thermometers. Warning: Do not use if package is opened or damaged. A very small percentage of people may be sensitive to lubricant ingredients. If irritation occurs, discontinue use and notify a physician. Do not use in eyes or ears. Storage: Store at room temperature. Ingredients: Water, Propylene Glycol, Hydroxypropyl Methylcellulose, Carbomer, Methylparaben, Propylparaben, Sodium Hydroxide (to adjust pH).

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):	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?
33587	General-body orifice lubricant, non-sterile	A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KMJ	Lubricant, patient

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: ccc16133-7813-4fa7-9c9f-5411ea0bb75a
Public Version Date: August 24, 2020
Public Version Number: 7
DI Record Publish Date: April 19, 2017