Regenesis Fertility Lubricant
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Basic Information
- Brand Name
- Regenesis Fertility Lubricant
- Primary DI
- 00893268000802
- Version / Model
- 5mL
- Catalog Number
- 200401
- Company Name
- GOOD CLEAN LOVE, INC.
- Labeler DUNS
- 153909531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-03
- Public Version
- 3
- Public Version Date
- 2025-10-20
- Public Version Status
- Update
- Public Device Record Key
- c15684f9-ca48-4d0f-a0c7-88f0d6619bda
Device Description
Regenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Regenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. Regenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Regenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
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 |
|---|---|---|---|---|
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 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 | 00893268000802 | GS1 | ||||
| Package | 00850014621971 | GS1 | Sample Case | 100 | In Commercial Distribution | |
| Package | 00850044065097 | GS1 | Case | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190872 | 000 |