Identity
- Trade Name
- Side Ported Needle - 20G FDA UDI
- Generic Name
- Compartmental-pressure monitoring system, single-use FDA UDI
- Device Name
- Side Ported Needle - 20G FDA UDI
- Model / Reference
- 0295-007-000 FDA UDI
- Description
- Side Ported Needle - 20G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850007350182 FDA UDI
- 510(k) Number
- K844214 FDA UDI
- FDA Product Code
- LXC FDA UDI
- GMDN Term
- Compartmental-pressure monitoring system, single-use FDA UDI
Classification
- Device Class
- U 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: Compartmental-pressure monitoring system, single-use
Side Ported Needle - 20G by C2dx, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Compartmental-pressure monitoring system, single-use.
- Quick Pressure Monitor Set — C2DX, INC. · U
- Quick Pressure Monitor Set (Japan) - 20G — C2DX, INC. · U
- Syringe, 3cc — C2DX, INC. · U
- Quick Pressure Monitor Set - 20G — C2DX, INC. · U
- Indwelling Slit Catheter — C2DX, INC. · U
- Side Ported Needle — C2DX, INC. · U
- Quick Pressure Monitor Set (Japan) — C2DX, INC. · U
Cleared under the same submission
K844214 also covers:
- Indwelling Slit Catheter — C2DX, INC.
- Quick Pressure Monitor Set — C2DX, INC.
- Quick Pressure Monitor Set (Japan) — C2DX, INC.
- Quick Pressure Monitor Set (Japan) - 20G — C2DX, INC.
- Quick Pressure Monitor Set - 20G — C2DX, INC.
- STIC Intracompartmental Pressure Monitor — C2DX, INC.
- Side Ported Needle — C2DX, INC.
- Syringe, 3cc — C2DX, 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 U | Pending data |
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Manufacturer
- Manufacturer
- C2dx, Inc.
Sources (1)
- FDA UDI 37023cab-ee38-4092-8305-beb5267c5290 35 fields · synced May 31, 2026