Identity
- Trade Name
- NAMIC FDA UDI
- Generic Name
- Contrast medium conservation system FDA UDI
- Device Name
- SQUEEZE CONTRAST CONTROLLER 72" FDA UDI
- Model / Reference
- 90400435 FDA UDI
- Description
- SQUEEZE CONTRAST CONTROLLER 72" FDA UDI
Identifiers
- Primary DI / UDI-DI
- H749904004350 FDA UDI
- 510(k) Number
- K903493 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- Contrast medium conservation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 72 Inch FDA UDI
Category: Contrast medium conservation system
Namic by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Contrast medium conservation system.
- DYETECT™ Contrast Monitoring Disposable Kit — Osprey Medical, Inc. · Class II
- DYEVERT™ PLUS EZ — Osprey Medical, Inc. · Class II
- DYEVERT™ NG — Osprey Medical, Inc. · Class II
- DYEVERT™ PLUS EZ — Osprey Medical, Inc. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- DYETECT™ Contrast Monitoring Disposable Kit — Osprey Medical, Inc. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 73be68fe-7441-4bd1-8ea3-09c3a79040fa 36 fields · synced May 31, 2026