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BT2000 Automated Manifold Kit

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
BT2000 Automated Manifold Kit FDA UDI
Generic Name
Contrast medium injection system administration set FDA UDI
Device Name
Model BT2000 p/n 701671-001 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer FDA UDI
Model / Reference
014613 FDA UDI
Description
Model BT2000 p/n 701671-001 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer FDA UDI

Identifiers

Primary DI / UDI-DI
10841716101974 FDA UDI
510(k) Number
K171646 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Contrast medium injection system administration set 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

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

BT2000 Automated Manifold 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 6f1cfc32-c49e-4e6f-a3e0-99a74fea84e2 35 fields · synced Jun 8, 2026