FDA UDI
In Commercial Distribution
🇺🇸 United States
Uricult® CLED+Polymyxin /EMB
DI: 06438115000013
·
Model: 68018
·
Aidian Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Uricult® CLED+Polymyxin /EMB
- Primary DI
- 06438115000013
- Version / Model
- 68018
- Catalog Number
- 1002
- Company Name
- Aidian Oy
- Labeler DUNS
- 401656868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-05-13
- Public Version
- 5
- Public Version Date
- 2020-03-02
- Public Version Status
- Update
- Public Device Record Key
- 1b567e70-d534-4c24-a082-d97dffd279e0
Device Description
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSI | Culture Media, Selective And Differential | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62106 | Multiple formulation agar culture medium IVD | A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438115000013 | GS1 | ||||
| Unit of Use | 06438115001065 | GS1 |
Customer Contacts
- Phone
- +358103093000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 45 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 25 Degrees Celsius