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, MALE, BLUE, W/TAB FDA UDI
- Model / Reference
- 100-204 EUDAMEDMale Flow-Through Configuration FDA UDI
- Description
- CONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, MALE, BLUE, W/TAB FDA UDI
Identifiers
- Catalog Number
- 100-204 FDA UDI
- Primary DI / UDI-DI
- H6711002040 EUDAMEDFDA 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
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
No
FDA UDI
Delta-Flow by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K780479 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
- Utah Medical Products, Inc.
Sources (2)
- FDA UDI 2108017c-6ab2-4405-920a-ac314f3e86ac 37 fields · synced Oct 6, 2026
- EUDAMED 8710bcd8-4cae-4f4d-94f4-05763abacc24 61 fields · synced Jun 20, 2026