Identity
- Trade Name
- PDI® Lubricating Jelly II FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices. FDA UDI
- Model / Reference
- T00137 FDA UDI
- Description
- Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices. FDA UDI
Identifiers
- Catalog Number
- T00137 FDA UDI
- Primary DI / UDI-DI
- 00310819000482 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2.7 Gram FDA UDI
PDI® Lubricating Jelly II by Professional Disposables International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Professional Disposables International, Inc.
Sources (1)
- FDA UDI ac1962dc-6cb6-4132-99f0-f4b2bb39bf07 37 fields · synced Jun 8, 2026