FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM BVBlue Transport Swabs
DI: 00742860100680
·
Model: 186
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
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Basic Information
- Brand Name
- OSOM BVBlue Transport Swabs
- Primary DI
- 00742860100680
- Version / Model
- 186
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2026-02-23
- Public Version
- 1
- Public Version Date
- 2026-03-03
- Public Version Status
- New
- Public Device Record Key
- 087f76c0-2ae6-4f23-bd5b-862e2292f5d9
Device Description
OSOM BVBlue Transport Swab Set
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
- Yes
- 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 |
|---|---|---|---|---|
| JTR | Kit, Quality Control For Culture Media | Microbiology | 866.2480 | 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 | 50742860100685 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00742860100680 | GS1 | ||||
| Unit of Use | 10742860100687 | GS1 |