FDA UDI
In Commercial Distribution
🇺🇸 United States
CautionWear L.A.Confidential - Dark Desire
DI: 00850836007113
·
Model: LAC0001DD
·
CAUTION WEAR CORP
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- CautionWear L.A.Confidential - Dark Desire
- Primary DI
- 00850836007113
- Version / Model
- LAC0001DD
- Company Name
- CAUTION WEAR CORP
- Labeler DUNS
- 177056145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 1
- Public Version Date
- 2021-06-29
- Public Version Status
- New
- Public Device Record Key
- edc8f934-e7b3-4991-8976-01e200555cad
Device Description
Male Latex Condom, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Tip, Lubricated With Ultra-Smooth Silicon-Based Lubricant
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 00850836007762 | GS1 | Plastic Bag | 24 | In Commercial Distribution | |
| Primary | 00850836007113 | GS1 | ||||
| Package | 00850836007779 | GS1 | Plastic Bag | 50 | In Commercial Distribution | |
| Package | 00850836007786 | GS1 | Plastic Bag | 100 | In Commercial Distribution | |
| Package | 00850836007793 | GS1 | Plastic Bag | 200 | In Commercial Distribution |
Customer Contacts
- Phone
- 603-598-8500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 100 Degrees Celsius