Identity
- Trade Name
- APLICARE FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- LUBRICATING JELLY PACKET, STERILE, 5 FDA UDI
- Model / Reference
- APL82281S FDA UDI
- Description
- LUBRICATING JELLY PACKET, STERILE, 5 FDA UDI
Identifiers
- Catalog Number
- APL82281S FDA UDI
- Primary DI / UDI-DI
- 10197344007042 FDA UDI
- FDA Product Code
- FHX FDA UDI
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-body orifice lubricant
Aplicare by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-body orifice lubricant.
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- Sterile Bacteriostatic Lubricating Gel — Micro-tech Usa · Class I
- DynaLube, Sterile, 2.7 g Packet — Dynarex Corp. · Class I
- NAR Kit — NORTH AMERICAN RESCUE, LLC. · Class I
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 5bc8e121-10a4-43bb-ac04-16e9747eff45 36 fields · synced May 30, 2026