Identity
- Trade Name
- RACT FDA UDI
- Generic Name
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
- Device Name
- CARTRIDGE 402-02 ACT RACT 13 LAN FDA UDI
- Model / Reference
- 402-02 FDA UDI
- Description
- CARTRIDGE 402-02 ACT RACT 13 LAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20643169577484 FDA UDI
- 510(k) Number
- K853198 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heparin anti-Xa IVD, kit, chromogenic
Ract by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heparin anti-Xa IVD, kit, chromogenic.
- INNOVANCE Heparin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Stachrom® Heparin — DIAGNOSTICA STAGO, INC. · Class II
- BIOPHEN HEPARIN 3 — HYPHEN BIOMED · Class II
- ACTICHROME HEPARIN (ANTI-FXA) — Biomedica ADI Inc. · Class II
- Coamatic Heparin — INSTRUMENTATION LABORATORY COMPANY · Class II
- STA® - Liquid Anti-Xa 4 — DIAGNOSTICA STAGO, INC. · Class II
- Coatest Heparin — INSTRUMENTATION LABORATORY COMPANY · Class II
- BIOPHEN HEPARIN 6 — HYPHEN BIOMED · Class II
Cleared under the same submission
K853198 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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 75e36e40-31fe-4b3c-93eb-c5961da5df92 36 fields · synced May 30, 2026