FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nixit
DI: 00627987071429
·
Model: Nixit Natural Lubricant
·
MAYER LABORATORIES, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nixit
- Primary DI
- 00627987071429
- Version / Model
- Nixit Natural Lubricant
- Catalog Number
- 70004
- Company Name
- MAYER LABORATORIES, INC.
- Labeler DUNS
- 175425982
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-16
- Public Version
- 1
- Public Version Date
- 2025-09-24
- Public Version Status
- New
- Public Device Record Key
- 0a678129-e4e0-4e3c-a8c5-81e389fdf6f0
- Distribution End Date
- 2025-09-19
Device Description
Natural Personal Lubricant 4 fl. oz.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUC | Lubricant, personal | Obstetrics/Gynecology | 884.5300 | 2 |
| KMJ | Lubricant, patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused. | No | Active |
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627987071429 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Fluid Ounce |