FDA UDI
In Commercial Distribution
🇺🇸 United States
Astroglide Gel Personal Lubricant
DI: 00015594010106
·
Model: 015594010106
·
BIOFILM, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Astroglide Gel Personal Lubricant
- Primary DI
- 00015594010106
- Version / Model
- 015594010106
- Company Name
- BIOFILM, INC
- Labeler DUNS
- 790780258
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-01
- Public Version
- 5
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 00b817aa-ce97-489c-a68e-44e90522ee52
Device Description
Astroglide Gel 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. This product is compatible with natural rubber latex and polyurethane condoms.
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
- 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 | 00015594010106 | GS1 |
Customer Contacts
- Phone
- 1-800-848-5900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003867 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 113 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 70 – 77 Degrees Fahrenheit