Identity
- Trade Name
- ulricheasyINJECT Max FDA UDI
- Generic Name
- MRI contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- ulricheasyINJECT Max 3 FDA UDI
- Model / Reference
- XD 10150 FDA UDI
- Description
- ulricheasyINJECT Max 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052536205479 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- MRI contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: MRI contrast medium injection system, line-powered, mobile
ulricheasyINJECT Max by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as MRI contrast medium injection system, line-powered, mobile.
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Cleared under the same submission
K233737 also covers:
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG
K241850 also covers:
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulrich medical disposables — Ulrich GmbH & Co. KG
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich GmbH & Co. KG
Sources (1)
- FDA UDI eda33dee-a292-44f2-8354-91f2eb4a53c6 34 fields · synced Jun 8, 2026