FDA UDI
In Commercial Distribution
🇺🇸 United States
BacterioScan 216Dx System
DI: B9090050
·
Model: Clear Cartridge - 4 Well
·
BACTERIOSCAN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BacterioScan 216Dx System
- Primary DI
- B9090050
- Version / Model
- Clear Cartridge - 4 Well
- Company Name
- BACTERIOSCAN, INC.
- Labeler DUNS
- 029599160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 1
- Public Version Date
- 2020-10-29
- Public Version Status
- New
- Public Device Record Key
- 49d26bf5-81b0-4dac-9fb8-c5c740b412c0
Device Description
Single disposable - no packaging
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBQ | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture | Microbiology | 866.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63609 | Microbial incubator/imaging system IVD | An electrically-powered device intended to provide ideal conditions for microbial growth with an incubator, and to capture digital images of the specimens contained within the incubator at specified time intervals. It consists of an incubator unit with multiple shelves, a camera and a display unit for microbial growth monitoring. The system automatically monitors and controls temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It may have an integrated robotic transfer arm for loading and unloading the incubator onto/from other instruments. The device may be a single unit or modular assembly. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B9090050 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172412 | 000 |