FDA UDI
In Commercial Distribution
🇺🇸 United States
ulrich medical disposables
DI: 04052536203703
·
Model: XD 10756
·
Ulrich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ulrich medical disposables
- Primary DI
- 04052536203703
- Version / Model
- XD 10756
- Company Name
- Ulrich GmbH & Co. KG
- Labeler DUNS
- 315494757
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 3
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- 40042c5c-3330-4a3f-a208-67c6a0cfa868
Device Description
Spike for MRI (CM) - holder s for ulricheasyINJECT MRI injectors
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47258 | Contrast medium injection system administration set | A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04052536203710 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 04052536203703 | GS1 | ||||
| Package | 04052536203727 | GS1 | 8 | In Commercial Distribution |