Identity
- Trade Name
- Pressure Opaque PE Tubing FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Pressure Opaque PE Tubing 2Ft. Line with Male and Female Luer Lock Connectors FDA UDI
- Model / Reference
- 040102001A FDA UDI
- Description
- Pressure Opaque PE Tubing 2Ft. Line with Male and Female Luer Lock Connectors FDA UDI
Identifiers
- Catalog Number
- 040102001A FDA UDI
- Primary DI / UDI-DI
- 00886333200849 FDA UDI
- 510(k) Number
- K781558 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Yes
FDA UDI
Category: Fluid transfer set, general-purpose
Pressure Opaque PE Tubing by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 7a16c5d9-b1fb-46d4-b823-07fa7f7866f2 37 fields · synced Jun 9, 2026