FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments GloCyte® Vacuum Preparation Station Assembly
DI: 00816068020153
·
Model: 111076
·
ADVANCED INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Instruments GloCyte® Vacuum Preparation Station Assembly
- Primary DI
- 00816068020153
- Version / Model
- 111076
- Catalog Number
- 111076
- Company Name
- ADVANCED INSTRUMENTS, INC.
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c96dbd9a-b490-45d3-b3d6-385e63c0cf9d
Device Description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge.
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
- No
- 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 |
|---|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58008 | Laboratory pump, vacuum | A mains electricity (AC-powered) pump designed for use in a laboratory to produce vacuum. It is typically used to support many laboratory activities/processes such as sample aspiration, separation, and drying. It has an electric motor typically connected to a rotating or membrane-type pump head that removes (sucks in) air to produce strong suction (vacuum). It is typically used to aspirate liquids from samples in various types of containers (e.g., microplates, test tubes), draw liquids through a filter, and create vacuum in containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816068020153 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152776 | 000 |