FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM Vaginal Transport Swab Set
DI: 00742860100314
·
Model: 185
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- OSOM Vaginal Transport Swab Set
- Primary DI
- 00742860100314
- Version / Model
- 185
- Catalog Number
- 185
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-04-05
- Public Version
- 1
- Public Version Date
- 2018-05-07
- Public Version Status
- New
- Public Device Record Key
- e6af052a-3808-4891-aa56-4c37957595a8
Device Description
OSOM Vaginal Transport Swab Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KXG | APPLICATOR, ABSORBENT TIPPED, STERILE | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62971 | Sexually transmitted infection (STI) testing vaginal specimen collection kit | A collection of sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the vagina for subsequent laboratory analysis and/or other investigations of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae and/or Trichomonas vaginalis]. It includes a transport container with no additives and includes a swab, brush, spatula, and/or other collection devices. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50742860100319 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00742860100314 | GS1 | ||||
| Unit of Use | 10742860100311 | GS1 |