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Embrace Pro Meter

FDA UDI

Class II (US FDA UDI)

by Omnis Health, Llc

Identity

Trade Name
Embrace Pro Meter FDA UDI
Generic Name
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Model / Reference
ALL01AB0200 FDA UDI

Identifiers

Primary DI / UDI-DI
00894030002390 FDA UDI
510(k) Number
K083628 FDA UDI
FDA Product Code
LFR FDA UDI
JJX FDA UDI
NBW FDA UDI
GMDN Term
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1660 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Home-use/point-of-care blood glucose monitoring system IVD

Embrace Pro Meter by Omnis Health, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use/point-of-care blood glucose monitoring system IVD.

Cleared under the same submission

K083628 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omnis Health, Llc

Sources (1)

  • FDA UDI 8ed4cb55-7a0c-4de3-8643-1cc45422acf6 33 fields · synced May 31, 2026