Identity
- Trade Name
- Single-use Syringe Kit FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Device Name
- Model A1000V, p/n 701259-012 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp FDA UDI
- Model / Reference
- 016605 FDA UDI
- Description
- Model A1000V, p/n 701259-012 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716102612 FDA UDI
- 510(k) Number
- K191060 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Contrast medium injection system syringe 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
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
Single-use Syringe Kit by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K191060 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
Sources (1)
- FDA UDI ac27382e-fe0f-40a7-8a78-c80ff4889064 35 fields · synced Jun 8, 2026