Identity
- Trade Name
- Rempress FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- Nemoto Rempress contrast delivery system for angiography, pedestal type unit. FDA UDI
- Model / Reference
- 100 FDA UDI
- Description
- Nemoto Rempress contrast delivery system for angiography, pedestal type unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560138481004 FDA UDI
- 510(k) Number
- K092896 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiography 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
No
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
No
FDA UDI
Category: Angiography contrast medium injection system, line-powered, mobile
Rempress by Nemoto Kyorindo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nemoto Kyorindo Co., Ltd.
Sources (1)
- FDA UDI 0e06183f-281b-4003-bd61-6af1579f3fc8 35 fields · synced Jun 6, 2026