FDA UDI
In Commercial Distribution
🇺🇸 United States
One Flex
DI: 30726893118332
·
Model: 113100C-BULK
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3000
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- One Flex
- Primary DI
- 30726893118332
- Version / Model
- 113100C-BULK
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3000
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 1
- Public Version Date
- 2024-09-11
- Public Version Status
- New
- Public Device Record Key
- 47d36dc8-f78b-41a0-9cce-b4e2394f8b6d
Device Description
Latex Condoms
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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 80726893118337 | GS1 | ||||
| Primary | 30726893118332 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203536 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature in a dark, dry place. Avoid excessive heat.