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Contrast Line
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 193356Ref 193364Ref 193359
Identity
- Trade Name
- Contrast Line EUDAMEDFDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Contrast Line EUDAMEDContrast Line 48"(122cm) Male/Female Polyurethane, Braided 1200 PSI FDA UDIContrast Line 30"(75cm) Female/Rotating Adapter PVC 1200 PSI FDA UDIContrast Line 20"(50cm) M/F (Braided) 1200 PSI FDA UDIContrast Line 30"(75cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI FDA UDI
- Model / Reference
- 193356 EUDAMEDFDA UDI193359 EUDAMEDFDA UDI193364 EUDAMEDFDA UDI193361 FDA UDI
- Description
- Contrast Line 48"(122cm) Male/Female Polyurethane, Braided 1200 PSI FDA UDIContrast Line 30"(75cm) Female/Rotating Adapter PVC 1200 PSI FDA UDIContrast Line 20"(50cm) M/F (Braided) 1200 PSI FDA UDIContrast Line 30"(75cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI FDA UDI
Identifiers
- Catalog Number
- 193361 FDA UDI193356 FDA UDI193359 FDA UDI193364 FDA UDI
- Primary DI / UDI-DI
- 20886333207408 EUDAMED20886333207484 EUDAMED20886333207439 EUDAMED00886333207459 FDA UDI00886333207404 FDA UDI00886333207435 FDA UDI00886333207480 FDA UDI
- Basic UDI-DI
- B-20886333207408 EUDAMEDB-20886333207484 EUDAMEDB-20886333207439 EUDAMED
- 510(k) Number
- K963749 FDA UDI
- FDA Product Code
- DTL FDA UDI
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Radiographic procedure tubing
Contrast Line by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K963749 also covers:
- Contrast Injection Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
- Contrast Line — Argon Medical Devices, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Argon Medical Devices, Inc.
Sources (7)
- FDA UDI e8a4d7f9-7175-4521-baa0-2058852bc4ae 37 fields · synced Jul 21, 2026
- FDA UDI 17c5488c-5b86-4762-bc44-c75967da1caa 37 fields · synced May 29, 2026
- FDA UDI 55adafec-ae86-44d3-8256-c0721feb5d70 37 fields · synced May 30, 2026
- FDA UDI 2bbe7112-3e6e-48bc-b6d5-ae90a677b54f 37 fields · synced May 30, 2026
- EUDAMED 69775746-e318-4a63-85af-10b7a726326c 61 fields · synced Jul 9, 2026
- EUDAMED f309af37-d6d9-4780-afb8-be213eee1699 61 fields · synced Jul 11, 2026
- EUDAMED 7f2002d5-ed94-4630-afbf-6aedfbc71621 61 fields · synced Jul 21, 2026