FDA UDI
In Commercial Distribution
🇺🇸 United States
DUREX Invisible Condom
DI: 00302340912778
·
Model: Condom
·
RB Health (us) LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
8
Basic Information
- Brand Name
- DUREX Invisible Condom
- Primary DI
- 00302340912778
- Version / Model
- Condom
- Company Name
- RB Health (us) LLC
- Labeler DUNS
- 081049410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2018-12-13
- Public Version Status
- Update
- Public Device Record Key
- 53fe8f48-e199-4c2a-8120-a03b1c751a04
Device Description
Condom
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HIS | CONDOM | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45138 | Basic male condom, Hevea-latex | A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20302340912772 | GS1 | Case | 16 | In Commercial Distribution | |
| Package | 10302340912775 | GS1 | Carton | 3 | In Commercial Distribution | |
| Primary | 00302340912778 | GS1 | ||||
| Unit of Use | 40302340912776 | GS1 |
Customer Contacts
- Phone
- +1(800)756-5488
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980319 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat