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A1000V Single Use Syringe Kit

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
A1000V Single Use Syringe Kit FDA UDI
Generic Name
Contrast medium injection system syringe FDA UDI
Device Name
A1000V Single Use Syringe Kit Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp. FDA UDI
Model / Reference
016605 FDA UDI
Description
A1000V Single Use Syringe Kit Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp. FDA UDI

Identifiers

Primary DI / UDI-DI
10841716102520 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
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

Yes

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: Contrast medium injection system syringe

A1000V Single Use Syringe Kit by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Contrast medium injection system syringe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACIST Medical Systems, Inc.

Sources (1)

  • FDA UDI 1709cd3d-037e-4cac-83df-972aef51729e 34 fields · synced Jun 8, 2026