FDA UDI
In Commercial Distribution
🇺🇸 United States
Pill Club
DI: 00060004114042
·
Model: Latex Condoms
·
MAYER LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pill Club
- Primary DI
- 00060004114042
- Version / Model
- Latex Condoms
- Catalog Number
- 11403
- Company Name
- MAYER LABORATORIES, INC.
- Labeler DUNS
- 175425982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-09
- Public Version
- 1
- Public Version Date
- 2022-02-17
- Public Version Status
- New
- Public Device Record Key
- ecc65498-8b67-4f9a-9102-11a51e668399
Device Description
12 ct Ultra Thin Latex Condoms
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- 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 | 20060004114046 | GS1 | carton | 1 | In Commercial Distribution | |
| Primary | 00060004114042 | GS1 |
Customer Contacts
- Phone
- +1(510)229-5300 ext. 5305
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 53 mm | ||
| Width | 53 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 90 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- HANDLING ENVIRONMENTAL TEMPERATURE