FDA UDI
In Commercial Distribution
🇺🇸 United States
Pharmaceutical Innovations
DI: 00300361500905
·
Model: Gentle Gel Lubricating Gel
·
PHARMACEUTICAL INNOVATIONS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pharmaceutical Innovations
- Primary DI
- 00300361500905
- Version / Model
- Gentle Gel Lubricating Gel
- Catalog Number
- 36-1500-90
- Company Name
- PHARMACEUTICAL INNOVATIONS INC
- Labeler DUNS
- 067486548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 87eca648-6a6f-4a03-bb2f-7b1bb4e7cb05
Device Description
Gentle Gel Lubricating Gel: 90 ml tube
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMS | Lubricant, Vaginal, Patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33587 | General-body orifice lubricant, non-sterile | A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00300361500905 | GS1 | ||||
| Package | 10300361500902 | GS1 | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 973-242-2900
- [email protected]