Identity
- Trade Name
- Meijer FDA UDI
- Generic Name
- Artificial saliva FDA UDI
- Device Name
- Saliva, Artificial FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- Saliva, Artificial FDA UDI
Identifiers
- Primary DI / UDI-DI
- D132DMS0030 FDA UDI
- 510(k) Number
- K181839 FDA UDI
- FDA Product Code
- LFD FDA UDI
- GMDN Term
- Artificial saliva FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
- Total Volume — 1.5 Fluid Ounce FDA UDI
Category: Artificial saliva
Meijer by Oralabs, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial saliva.
- THERABREATH RINSE — Church & Dwight Co., Inc. · U
- Biotene — Haleon US Holdings LLC · U
- Biotene — Haleon US Holdings LLC · U
- Moisyn Dry Mouth Oral Mist — Synedgen, Inc. · U
- Salivea — Laclede, Inc. · U
- SalivaMAX — FORWARD SCIENCE TECHNOLOGIES LLC · U
- Biotene Oral Rinse Dry Mouth — Haleon US Holdings LLC · U
- THERABREATH LOZENGE — Church & Dwight Co., Inc. · U
Cleared under the same submission
K181839 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Oralabs, Inc.
Sources (1)
- FDA UDI 266dccc7-8967-4428-b202-aa76967ae2c1 35 fields · synced May 30, 2026