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BloodTrack

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name
BloodTrack FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Device Name
BloodTrack version 4.x.x FDA UDI
Model / Reference
4.x.x FDA UDI
Description
BloodTrack version 4.x.x FDA UDI

Identifiers

Primary DI / UDI-DI
00812747010002 FDA UDI
FDA Product Code
MMH FDA UDI
GMDN Term
Clinical laboratory information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9165 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

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: Clinical laboratory information system application software

BloodTrack by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical laboratory information system application software.

Cleared under the same submission

BK140133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Haemonetics Corporation

Sources (1)

  • FDA UDI 5fdef371-8159-405f-8cfa-52565eb2916e 35 fields · synced Jun 8, 2026