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Easy Plus II Control Solution - HIGH

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name
Easy Plus II Control Solution - HIGH FDA UDI
Generic Name
Glucose IVD, control FDA UDI
Device Name
Blood glucose control solution for use with Easy Plus II blood glucose testing system FDA UDI
Model / Reference
GOD31 FDA UDI
Description
Blood glucose control solution for use with Easy Plus II blood glucose testing system FDA UDI

Identifiers

Catalog Number
1683 FDA UDI
Primary DI / UDI-DI
00891237001683 FDA UDI
FDA Product Code
NBW FDA UDI
JJX FDA UDI
GMDN Term
Glucose IVD, control 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 3 Milliliter FDA UDI

Category: Glucose IVD, control

Easy Plus II Control Solution - HIGH by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 2f71771e-a4dd-4b1b-a951-b84fbf50a445 37 fields · synced May 30, 2026