Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- General-body orifice lubricant, non-sterile FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- LJ33121 FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- LJ33121 FDA UDI
- Primary DI / UDI-DI
- 10885380100321 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- General-body orifice lubricant, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-body orifice lubricant, non-sterile
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI ccc16133-7813-4fa7-9c9f-5411ea0bb75a 34 fields · synced Jun 8, 2026