FDA UDI
In Commercial Distribution
🇺🇸 United States
UL_INJECT
DI: 04052536002245
·
Model: XD 8000
·
Ulrich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UL_INJECT
- Primary DI
- 04052536002245
- Version / Model
- XD 8000
- Catalog Number
- XD 8000
- Company Name
- Ulrich GmbH & Co. KG
- Labeler DUNS
- 315494757
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-12
- Public Version
- 3
- Public Version Date
- 2022-04-29
- Public Version Status
- Update
- Public Device Record Key
- bb1918ab-848f-42f7-8765-bb4881b49850
Device Description
XD 8000, ulrichINJECT CT motion composed of:
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| IZQ | Injector, contrast medium, automatic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57999 | CT contrast medium injection system, line-powered, mobile | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04052536002245 | GS1 |
Customer Contacts
- Phone
- +4907319654152
- [email protected]