Identity
- Trade Name
- LF FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Dual CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spikes FDA UDI
- Model / Reference
- 844023P FDA UDI
- Description
- Dual CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spikes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10746190004264 FDA UDI
- 510(k) Number
- K042744 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiography kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Total Volume — 200 Milliliter FDA UDIPressure — 400 Pound per Square Inch FDA UDIPressure — 2758 KiloPascal FDA UDI
Lf by Liebel-Flarsheim Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Liebel-Flarsheim Company, LLC
Sources (1)
- FDA UDI 39c8f70d-b67a-4425-b7e5-a1ed71a95c2f 36 fields · synced May 30, 2026