FDA UDI
In Commercial Distribution
🇺🇸 United States
ulrich medical disposables
DI: 04052536166459
·
Model: XD 10701
·
Ulrich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ulrich medical disposables
- Primary DI
- 04052536166459
- Version / Model
- XD 10701
- 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
- 3d8d4763-0632-4d94-8d26-e8f2f24df3fb
Device Description
Patient tubing, 250 cm for ulricheasyINJECT CT/MRT 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 |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04052536166466 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 04052536166459 | GS1 |