FDA UDI
In Commercial Distribution
🇺🇸 United States
binx io
DI: 05060441760036
·
Model: V1 (CT/NG)
·
BINX HEALTH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- binx io
- Primary DI
- 05060441760036
- Version / Model
- V1 (CT/NG)
- Catalog Number
- 5.002.001
- Company Name
- BINX HEALTH LIMITED
- Labeler DUNS
- 347089851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-03
- Public Version
- 1
- Public Version Date
- 2025-09-11
- Public Version Status
- New
- Public Device Record Key
- 74b7266e-c6e5-4e5a-9d48-fa808392b34b
Device Description
Male collection kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIO | Device, Specimen Collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61144 | Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical | A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15060441760033 | GS1 | Foil pouch | 50 | In Commercial Distribution | |
| Primary | 05060441760036 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200533 | 000 |