Identity
- Trade Name
- DELTA-FLOW EUDAMEDFDA UDI
- Generic Name
- Vascular catheter flush valve, continuous FDA UDI
- Device Name
- Deltran EUDAMEDCONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, Y-CONFIGURATION, BLUE W/TAB FDA UDICONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, MALE, BLUE, W/TAB FDA UDI
- Model / Reference
- 100-204 EUDAMEDY-Configuration FDA UDIMale Flow-Through Configuration FDA UDI
- Description
- CONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, Y-CONFIGURATION, BLUE W/TAB FDA UDICONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, MALE, BLUE, W/TAB FDA UDI
Identifiers
- Catalog Number
- 100-205 FDA UDI100-204 FDA UDI
- Primary DI / UDI-DI
- H6711002040 EUDAMEDFDA UDIH6711002050 FDA UDI
- Basic UDI-DI
- ++H671CE004IIAC7 EUDAMED
- 510(k) Number
- K780479 FDA UDI
- FDA Product Code
- KRA FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Vascular catheter flush valve, continuous FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vascular catheter flush valve, continuous
Delta-Flow by Utah Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter flush valve, continuous.
- Surseal® II — APPLIED MEDICAL RESOURCES CORP. · Class II
- Forté® Y- Adapter Seal — APPLIED MEDICAL RESOURCES CORP. · Class I
- DELTA-FLOW — Utah Medical Products, Inc. · Class II
- DELTRAN — Utah Medical Products, Inc. · Class II
- DELTRAN — Utah Medical Products, Inc. · Class II
- DELTRAN — Utah Medical Products, Inc. · Class II
- DELTRAN — Utah Medical Products, Inc. · Class II
- DELTRAN — Utah Medical Products, Inc. · Class II
Cleared under the same submission
K780479 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (3)
- FDA UDI a68c04ad-3b44-473c-a345-056bfb587a2f 37 fields · synced Jun 20, 2026
- FDA UDI 2108017c-6ab2-4405-920a-ac314f3e86ac 37 fields · synced May 30, 2026
- EUDAMED 8710bcd8-4cae-4f4d-94f4-05763abacc24 61 fields · synced Jun 20, 2026