FDA UDI
In Commercial Distribution
🇺🇸 United States
DianaTM Compounding Workflow System
DI: 00887709126589
·
Model: DS2010-04-01
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DianaTM Compounding Workflow System
- Primary DI
- 00887709126589
- Version / Model
- DS2010-04-01
- Catalog Number
- DS2010-04-01
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-10
- Public Version
- 1
- Public Version Date
- 2023-04-18
- Public Version Status
- New
- Public Device Record Key
- f6240192-912e-4c2d-b8ef-96f517e4f364
Device Description
US Power Cord Assembly, Diana
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
- Yes
- 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 |
|---|---|---|---|---|
| NEP | System/device, pharmacy compounding | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887709126589 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handling Environment Temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius