Duns Number:961027315
Device Description: Cardinal Health Lubricating Jelly Net Wt 0.11oz (3g)-Bacteriostatic -CHG-Free -Water-solub Cardinal Health Lubricating Jelly Net Wt 0.11oz (3g)-Bacteriostatic -CHG-Free -Water-soluble -Greaseless -UnscentedSterileProduct is sterile unless package is damagedor opened. Do not re-sterilize. Not Made withNatural Rubber Latex.To open aseptically, sanitize tube tip and cap with atopical antiseptic, such as an alcohol wipe, prior toopening. Remove cap and peel o_ seal. Replace cap.Lubricating jelly is water soluble, stable, non-greasyand spreads evenly. It is ideal for lubricating rubberproducts, such as catheters and rectal thermometers.Warning: Do not use if package is opened ordamaged. A very small percentage of people maybe sensitive to lubricant ingredients. If irritationoccurs, 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, SodiumHydroxide (to adjust pH).
Catalog Number
LJ33107G
Brand Name
CARDINAL HEALTH
Version/Model Number
LJ33107
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMJ
Product Code Name
Lubricant, patient
Public Device Record Key
c9cc30bc-5f04-4278-b3c0-f072d00b50ee
Public Version Date
August 24, 2020
Public Version Number
4
DI Record Publish Date
April 22, 2019
Package DI Number
50885380100695
Quantity per Package
48
Contains DI Package
20885380100694
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |