FDA UDI
In Commercial Distribution
🇺🇸 United States
ID Millennium
DI: 00761236109928
·
Model: Millennium 12 ml Tube
·
WESTRIDGE LABORATORIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- ID Millennium
- Primary DI
- 00761236109928
- Version / Model
- Millennium 12 ml Tube
- Catalog Number
- IDDMIT10
- Company Name
- WESTRIDGE LABORATORIES INCORPORATED
- Labeler DUNS
- 879057065
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- bd9903cc-6419-4212-98b3-765a1e3b9ced
Device Description
ID Millennium is a Silicone based lubricant, and is Latex Compatible.
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
- 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 |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. 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 | 00761236109928 | GS1 | ||||
| Package | 00761236109942 | GS1 | Jar | 72 | In Commercial Distribution | |
| Package | 00761236109935 | GS1 | Bag | 72 | In Commercial Distribution | |
| Package | 60761236109920 | GS1 | Case | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 17142599400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141767 | 000 |