FDA UDI
In Commercial Distribution
🇺🇸 United States
Kimono
DI: 00016169030031
·
Model: MAXX Large Flare
·
MAYER LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
3
Basic Information
- Brand Name
- Kimono
- Primary DI
- 00016169030031
- Version / Model
- MAXX Large Flare
- Catalog Number
- 03003
- Company Name
- MAYER LABORATORIES, INC.
- Labeler DUNS
- 175425982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 11591a48-6a89-4bb8-ac2a-6fcd75940b67
Device Description
Latex Condom 3-ct
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 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 | 10016169030038 | GS1 | MASTER CARTON | 8 | In Commercial Distribution | |
| Package | 20016169030035 | GS1 | SHRINK WRAP | 6 | In Commercial Distribution | |
| Primary | 00016169030031 | GS1 | ||||
| Unit of Use | 30016169030032 | GS1 |
Customer Contacts
- Phone
- +1(510)229-5300 ext. 5305
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K941258 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 53mm x 180mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- NO DIRECT SUNLIGHT OR HEAT
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 90 Degrees Fahrenheit