ACTtrac®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: ACTtrac® FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Device Name: CONSOLE 31363 ACTTRAC CE IVDD NON-ROHS FDA UDI
Model / Reference: 31363 FDA UDI
Description: CONSOLE 31363 ACTTRAC CE IVDD NON-ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000135461 FDA UDI
510(k) Number: K953870 FDA UDI
FDA Product Code: GKN FDA UDI
GMDN Term: Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, control

ACTtrac® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multiple coagulation factor IVD, control.

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Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
JAS Diagnostics — Drew Scientific , Ltd.
CueSee® Coag — Eurotrol B.V. · Class II
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I

Cleared under the same submission

K953870 also covers:

ACTtrac® — MEDTRONIC, INC.

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: Medtronic, Inc.

Sources (1)

FDA UDI ad3f963f-1fb7-47be-b749-c60f41b49ca1 36 fields · synced May 31, 2026