FDA UDI
In Commercial Distribution
🇺🇸 United States
SalivaBio
DI: 00859410006344
·
Model: N/A
·
SALIMETRICS, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SalivaBio
- Primary DI
- 00859410006344
- Version / Model
- N/A
- Catalog Number
- 5001.06B
- Company Name
- SALIMETRICS, LLC
- Labeler DUNS
- 084843064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-24
- Public Version
- 1
- Public Version Date
- 2025-12-02
- Public Version Status
- New
- Public Device Record Key
- f7f33f1a-c792-4cf1-a495-c26082407d82
Device Description
SalivaBio Children's Swab (SCS) Bulk PK/100
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65459 | Oral/upper respiratory tract specimen collection swab IVD | An in vitro diagnostic device in the form of a piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859410006344 | GS1 |