FDA UDI
In Commercial Distribution
🇺🇸 United States
BioNude Ultra Sensitive Personal Lubricant
DI: 00893268000260
·
Model: 5 mL
·
GOOD CLEAN LOVE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- BioNude Ultra Sensitive Personal Lubricant
- Primary DI
- 00893268000260
- Version / Model
- 5 mL
- Catalog Number
- 200705
- Company Name
- GOOD CLEAN LOVE, INC.
- Labeler DUNS
- 153909531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-12
- Public Version
- 4
- Public Version Date
- 2023-09-25
- Public Version Status
- Update
- Public Device Record Key
- 5bc65e6e-afaf-4e31-aca3-645ecee41b2e
Device Description
Personal lubricant for vaginal/penile application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
Device Characteristics
- Single Use
- Yes
- 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 | 00893268000260 | GS1 | ||||
| Package | 30850014621217 | GS1 | Master Case | 900 | Not in Commercial Distribution | 2023-02-06 |
| Package | 30893268000261 | GS1 | Master Case | 900 | In Commercial Distribution | |
| Package | 00850014621964 | GS1 | Sample Case | 100 | In Commercial Distribution | |
| Package | 00850044065080 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 541-344-4483
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180136 | 000 |