FDA UDI
In Commercial Distribution
🇺🇸 United States
Astroglide Organix Liquid
DI: 00015594011653
·
Model: 015594011653
·
BIOFILM, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Astroglide Organix Liquid
- Primary DI
- 00015594011653
- Version / Model
- 015594011653
- Catalog Number
- N/A
- Company Name
- BIOFILM, INC
- Labeler DUNS
- 790780258
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-10
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- ef58587d-d041-4f04-b76b-fd93eff1d49d
Device Description
Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.
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
- Yes
- 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 | 00015594011653 | GS1 |
Customer Contacts
- Phone
- 1-800-848-5900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200114 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2.5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 70 – 77 Degrees Fahrenheit