FDA UDI
In Commercial Distribution
🇺🇸 United States
BD™ FocalPoint™ Slide Profiler Refurbished
DI: 00382904914905
·
Model: 491490
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD™ FocalPoint™ Slide Profiler Refurbished
- Primary DI
- 00382904914905
- Version / Model
- 491490
- Catalog Number
- 491490
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-08
- Public Version
- 2
- Public Version Date
- 2023-10-13
- Public Version Status
- Update
- Public Device Record Key
- bdeb2c3c-c896-4017-a223-ba4d7db97e06
Device Description
Focal Point Digital Refurb 2
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
- 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 |
|---|---|---|---|---|
| MNM | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15132 | Cell morphology analyser IVD, manual | An electrically-powered manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904914905 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature