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FreeStyle Precision H

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
FreeStyle Precision H FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI
Device Name
FreeStyle Precision H Blood Glucose and Ketone Monitoring System FDA UDI
Model / Reference
71181 FDA UDI
Description
FreeStyle Precision H Blood Glucose and Ketone Monitoring System FDA UDI

Identifiers

Catalog Number
71181 FDA UDI
Primary DI / UDI-DI
00093815711810 FDA UDI
510(k) Number
K070984 FDA UDI
FDA Product Code
LFR FDA UDI
NBW FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, point-of-care

FreeStyle Precision H by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, point-of-care.

Cleared under the same submission

K070984 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 5f12193b-2089-442d-92cd-9993f1f3cab0 37 fields · synced Jun 1, 2026