FDA UDI In Commercial Distribution 🇺🇸 United States

CARDINAL HEALTH

DI: 10885380111419 · Model: LJ33183G · Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
CARDINAL HEALTH
Primary DI
10885380111419
Version / Model
LJ33183G
Catalog Number
LJ33183G
Company Name
Cardinal Health 200, LLC
Labeler DUNS
961027315
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-04-22
Public Version
4
Public Version Date
2020-08-24
Public Version Status
Update
Public Device Record Key
2fab55fd-20e9-4b04-b93c-449b389666f9

Device Description

Cardinal Health Lubricating Jelly Net Wt 0.32oz (5g) -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

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KMJ Lubricant, patient

GMDN Terms

Code Name
33587 General-body orifice lubricant, non-sterile

Identifiers

Type ID
Package 50885380100350
Package 20885380100359
Primary 10885380111419