FDA UDI
In Commercial Distribution
🇺🇸 United States
CautionWear Black Ice
DI: 00850836007359
·
Model: CW0001BI
·
CAUTION WEAR CORP
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- CautionWear Black Ice
- Primary DI
- 00850836007359
- Version / Model
- CW0001BI
- Company Name
- CAUTION WEAR CORP
- Labeler DUNS
- 177056145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 61d4233c-b89d-44f2-ae72-378d531b32a4
Device Description
Male Latex Condom, Parallel-Sided, Smooth Surface, Ultra Thin, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
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 | 00850836007373 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 00850836007366 | GS1 | Inner Pack | 1000 | In Commercial Distribution | |
| Primary | 00850836007359 | GS1 | ||||
| Package | 00850836007380 | GS1 | Case | 4000 | In Commercial Distribution |
Customer Contacts
- Phone
- 603-598-8500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012665 | 000 |