Identity
- Trade Name
- Coeur FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- 40 in. Transfer Set with Dual Check Valve and Short Spike FDA UDI
- Model / Reference
- C405-3409 FDA UDI
- Description
- 40 in. Transfer Set with Dual Check Valve and Short Spike FDA UDI
Identifiers
- Catalog Number
- C405-3409 FDA UDI
- Primary DI / UDI-DI
- M297134090 FDA UDI
- 510(k) Number
- K063114 FDA UDI
- FDA Product Code
- FPA FDA UDIFPK FDA UDI
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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 — 40 Inch FDA UDI
Category: Radiographic procedure tubing
Coeur by Coeur, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiographic procedure tubing.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- High Pressure Tubing, Keep™ — Merit Medical Systems, Inc. · Class II
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd. · Class II
- MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable — Bayer Medical Care Inc. · Class II
- MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector — Bayer Medical Care Inc. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K063114 also covers:
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
- Coeur, Inc.
Sources (1)
- FDA UDI eff1c7b7-d9b3-404c-a720-d9e0254a5d77 38 fields · synced May 30, 2026