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Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Device Name
CONTROL,EVENCARE G2 HI LO FDA UDI
Model / Reference
MPH1560 FDA UDI
Description
CONTROL,EVENCARE G2 HI LO FDA UDI

Identifiers

Catalog Number
MPH1560 FDA UDI
Primary DI / UDI-DI
00884389102544 FDA UDI
FDA Product Code
JJX FDA UDI
NBW FDA UDI
GMDN Term
Home-use/point-of-care blood glucose monitoring system IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
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

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

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

Medline by Medline Industries, Inc. — Class I — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f6dfef5b-a8a9-4d7b-9560-febc5fda5b71 36 fields · synced Jun 1, 2026