FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica Biosystems CytoVision Replace CW4000 with CV Capture+Jai M4
DI: 00849832005094
·
Model: 23CW4000UP001
·
Leica Biosystems Richmond, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica Biosystems CytoVision Replace CW4000 with CV Capture+Jai M4
- Primary DI
- 00849832005094
- Version / Model
- 23CW4000UP001
- Company Name
- Leica Biosystems Richmond, Inc.
- Labeler DUNS
- 082930884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 3
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 1bb96d64-3b48-45b2-a08d-ee90ba4ebf5a
Device Description
Leica Biosystems CytoVision Replace CW4000 with CV Capture+Jai M4
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 |
|---|---|---|---|---|
| JOY | DEVICE, AUTOMATED CELL-LOCATING | Hematology | 864.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35576 | Surgical microscope still camera | An electro-optical device intended to be used to capture and generate an enlarged image of a microscopic field for examination of a clinical specimen during a surgical procedure. It is designed to attach to a surgical microscope and utilizes the lens system for magnification of the microscope’s field; the images generated are used for subsequent clinical decision-making. This device may be a digital or photographic camera; some types may in addition be used with laboratory microscopes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849832005094 | GS1 |
Customer Contacts
- Phone
- +1(800)5374669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify