Identity
- Trade Name
- Coeur nemoto FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- 100mL/100mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes FDA UDI
- Model / Reference
- C855-5178 FDA UDI
- Description
- 100mL/100mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes FDA UDI
Identifiers
- Catalog Number
- C855-5178 FDA UDI
- Primary DI / UDI-DI
- M902551780 FDA UDI
- 510(k) Number
- K051799 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe 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
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
- Total Volume — 100 Milliliter FDA UDI
Category: Angiographic syringe
The Coeur nemoto angiographic syringe is a sterile, manually-operated device designed for the administration of contrast media into the heart, great vessels, and coronary arteries. It may also be used to introduce other fluids. This single-use device is intended for implantation purposes and has not been approved for use in humans.
Similar devices
Also classified as Angiographic syringe.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
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- Inject8™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K051799 also covers:
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
- Coeur Nemoto — Coeur, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coeur, Inc.
Sources (1)
- FDA UDI 74c519fc-c805-4330-82b9-d7809bd40e2e 38 fields · synced Jul 25, 2026