FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Leica Biosystems DELL 7910 CV Ultimate Service PC
DI: 00849832010920
·
Model: 23CPU7910ULT_SPARE
·
Leica Biosystems Richmond, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Leica Biosystems DELL 7910 CV Ultimate Service PC
- Primary DI
- 00849832010920
- Version / Model
- 23CPU7910ULT_SPARE
- Company Name
- Leica Biosystems Richmond, Inc.
- Labeler DUNS
- 082930884
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-03
- Public Version
- 5
- Public Version Date
- 2025-03-10
- Public Version Status
- Update
- Public Device Record Key
- 95d15449-ec98-478b-9ead-bc78f841b1d1
- Distribution End Date
- 2025-03-07
Device Description
Leica Biosystems DELL 7910 CV Ultimate Service PC
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
- No
- 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 |
|---|---|---|---|---|
| JOY | DEVICE, AUTOMATED CELL-LOCATING | Hematology | 864.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38452 | Desktop computer | A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849832010920 | GS1 |
Customer Contacts
- Phone
- +1(800)5374669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042542 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify