FDA UDI
In Commercial Distribution
🇺🇸 United States
APAS Independence
DI: 09354646000001
·
Model: A
·
Clever Culture Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APAS Independence
- Primary DI
- 09354646000001
- Version / Model
- A
- Catalog Number
- AI-16001
- Company Name
- Clever Culture Systems AG
- Labeler DUNS
- 487097888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-23
- Public Version
- 1
- Public Version Date
- 2020-03-31
- Public Version Status
- New
- Public Device Record Key
- 19f5f5a7-c60f-438d-92a8-88df6c95ba68
Device Description
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| PPU | Microbial Colony Image Assessment System | Microbiology | 866.2190 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64148 | Microbial culture plate imaging/analysis system IVD | An electrically-powered device intended to be used for the imaging and assessment of pre-inoculated, pre-incubated microbial culture plates. It typically consists of a sample handling/preparation unit, digital camera, optical reader, transfer unit and dedicated software for image capture, processing and/or analysis. It is not intended for incubation. The system may be a single self-contained unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09354646000001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183648 | 000 |