FDA UDI
In Commercial Distribution
🇺🇸 United States
Hallelubeyah
DI: 00869521000353
·
Model: Lube-1
·
LOVABILITY LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hallelubeyah
- Primary DI
- 00869521000353
- Version / Model
- Lube-1
- Company Name
- LOVABILITY LLC
- Labeler DUNS
- 116995012
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-12
- Public Version
- 2
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 02dd7b19-0db4-497b-95af-bfbaadc77cad
Device Description
Our personal lubricant is an intimate moisturizer made with the vine extract of the New Zealand kiwifruit plant harvested from orchards in the Province of Auckland, New Zealand. Through a proprietary extraction process, the natural film like lubricant is collected, the composition of which is similar to that of what the body produces. Hallelubeyah personal lubricant is formulated to be a non sterile, non greasy, non sticky, non staining, viscous liquid with a pH range of 4.4 to 4.7 to match the vaginal region for the majority of a women’s cycle. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 1 ounce tubes.
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 |
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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869521000353 | GS1 |
Customer Contacts
- Phone
- 1-310-956-1432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152646 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Fluid Ounce |