FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Kiestra™ Stacker
DI: 00382904469474
·
Model: 446947
·
BD Kiestra B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Kiestra™ Stacker
- Primary DI
- 00382904469474
- Version / Model
- 446947
- Catalog Number
- 446947
- Company Name
- BD Kiestra B.V.
- Labeler DUNS
- 417876166
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-19
- Public Version
- 1
- Public Version Date
- 2023-10-27
- Public Version Status
- New
- Public Device Record Key
- 07776c28-fcf3-4ea6-960f-4ab59e5d9683
Device Description
BD Kiestra Stacker
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
- Yes
- 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 |
|---|---|---|---|---|
| JQP | Calculator/data processing module, for clinical use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58025 | Laboratory container/microscope slide robotic transfer system IVD | An assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904469474 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Environment Temp - Celsius