FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica Biosystems Back-UPS Pro 1300VA 110V
DI: 00849832010821
·
Model: 23UPS0004
·
Leica Biosystems Richmond, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica Biosystems Back-UPS Pro 1300VA 110V
- Primary DI
- 00849832010821
- Version / Model
- 23UPS0004
- Company Name
- Leica Biosystems Richmond, Inc.
- Labeler DUNS
- 082930884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eb13c67a-902b-41b1-9a28-ccd2cd9d5094
Device Description
Back-UPS Pro 1300VA 110V
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 |
|---|---|---|---|---|
| 38489 | Uninterruptible power supply | A portable device, commonly known as an uninterruptible power supply (UPS), designed to provide a continuous supply of electrical power for a limited period of time to a connected device or devices during the failure of the mains electricity (AC-power) supply due to an emergency situation, e.g., a blackout, or maintenance/testing. It will contain its own set of batteries that normally maintain their charge from the mains power supply and it is these that provide the power when a failure in the line-power occurs. This device is used locally (at the point of use) and is often reserved to supply vital devices, e.g., ventilators, patient monitoring devices and computer dependent devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849832010821 | 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