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Embrace Pro Control Solution (L1/Normal +1 more model

FDA UDI

Class I (US FDA UDI)

by Omnis Health, Llc

Identity

Trade Name
Embrace Pro Control Solution (L1/Normal; L2/High) FDA UDI
Generic Name
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Model / Reference
ALL02AB0210 FDA UDI

Identifiers

Primary DI / UDI-DI
00894030002413 FDA UDI
510(k) Number
K083628 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Models / Variants
Embrace Pro Control Solution (L1/Normal FDA UDI
L2/High) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

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 Control Solution (L1/Normal +1 more model by Omnis Health, Llc — Class I — FDA UDI — listed in FDA GUDID — 2 models — 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 baa3096b-13f4-4e22-9533-52406a2d6191 33 fields · synced May 30, 2026