Identity
- Trade Name
- Ecomed Angiographic FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- CT 200mL LF Syringe Kit Includes (1) 60" coiled tubing (1) fill straw FDA UDI
- Model / Reference
- 128-200101 FDA UDI
- Description
- CT 200mL LF Syringe Kit Includes (1) 60" coiled tubing (1) fill straw FDA UDI
Identifiers
- Catalog Number
- 128-200101 FDA UDI
- Primary DI / UDI-DI
- 00855009006009 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
- 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
Yes
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 200 Milliliter FDA UDILength — 60 Inch FDA UDI
Category: Angiography kit
Ecomed Angiographic by Ecomed Solutions, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ecomed Solutions, LLC
Sources (1)
- FDA UDI facec99f-246a-4ffa-9cbb-d25e16d59dea 37 fields · synced Jun 9, 2026