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Pressure Monitoring Lines Opaque PE Tubing
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 040204001A
Identity
- Trade Name
- PE Tubing EUDAMEDPressure Monitoring Lines Opaque PE Tubing FDA UDIPressure Monitoring Lines FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- PE Tubing EUDAMEDPressure Monitoring Lines Opaque PE Tubing 6Ft. Line w/Male Luer Lock Connectors on each End FDA UDIPressure Monitoring Lines Pressure Opaque PE Tubing Tubing 4Ft. Line w/Male Luer Lock Connectors on each End FDA UDI
- Model / Reference
- 040204001A EUDAMEDFDA UDI040206001A FDA UDI
- Description
- Pressure Monitoring Lines Opaque PE Tubing 6Ft. Line w/Male Luer Lock Connectors on each End FDA UDIPressure Monitoring Lines Pressure Opaque PE Tubing Tubing 4Ft. Line w/Male Luer Lock Connectors on each End FDA UDI
Identifiers
- Catalog Number
- 040206001A FDA UDI040204001A FDA UDI
- Primary DI / UDI-DI
- 20886333201154 EUDAMED00886333201204 FDA UDI00886333201150 FDA UDI
- Basic UDI-DI
- B-20886333201154 EUDAMED
- 510(k) Number
- K781558 FDA UDI
- FDA Product Code
- DQO FDA UDI
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 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: Fluid transfer set, general-purpose
Pressure Monitoring Lines Opaque PE Tubing by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K781558 also covers:
- Pressure Monitoring Injection Line — Argon Medical Devices, Inc.
- Pressure Monitoring Injection Line — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — Argon Medical Devices, Inc.
- Pressure Monitoring Lines — 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 |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (3)
- FDA UDI 9ff446b3-7fe2-41d8-990e-ab18d4e45b72 37 fields · synced Oct 6, 2026
- FDA UDI 0dd66d25-5de8-450b-bc76-155ce222d735 37 fields · synced May 30, 2026
- EUDAMED cd225a8d-891c-4346-91e4-ebc419a7c57c 61 fields · synced Jul 25, 2026