FDA UDI
In Commercial Distribution
🇺🇸 United States
FPA
DI: 00850836007335
·
Model: CU0001FPA
·
CAUTION WEAR CORP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FPA
- Primary DI
- 00850836007335
- Version / Model
- CU0001FPA
- Company Name
- CAUTION WEAR CORP
- Labeler DUNS
- 177056145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 335edd33-e430-4ea1-9ad3-7166bb1ce905
Device Description
Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), 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 | 00850836007342 | GS1 | Case | 4000 | In Commercial Distribution | |
| Primary | 00850836007335 | GS1 |
Customer Contacts
- Phone
- 603-598-8500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002393 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 100 Degrees Fahrenheit