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A2000 Multi-use Syringe Kit

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
A2000 Multi-use Syringe Kit FDA UDI
Generic Name
Contrast medium injection system syringe FDA UDI
Device Name
A2000 Multi-use Syringe Kit, p/n 701669-002 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps FDA UDI
Model / Reference
014612 FDA UDI
Description
A2000 Multi-use Syringe Kit, p/n 701669-002 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps FDA UDI

Identifiers

Primary DI / UDI-DI
10841716101684 FDA UDI
510(k) Number
K171646 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

No

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

A2000 Multi-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

K171646 also covers:

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 41240884-c4a3-4ca0-a40d-dfc856dc5311 35 fields · synced Jun 8, 2026