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SmartDose Evolution

FDA UDI

Class II (US FDA UDI)

by Inovo, Inc.

Identity

Trade Name
SmartDose Evolution FDA UDI
Generic Name
Non-fixed medical gas cylinder regulator FDA UDI
Device Name
SmartDose Evolution Electronic Conserver FDA UDI
Model / Reference
OM-975 FDA UDI
Description
SmartDose Evolution Electronic Conserver FDA UDI

Identifiers

Catalog Number
OM-975 FDA UDI
Primary DI / UDI-DI
00822383024875 FDA UDI
510(k) Number
K103392 FDA UDI
FDA Product Code
NFB FDA UDI
GMDN Term
Non-fixed medical gas cylinder regulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 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

Yes

FDA UDI

Prescription Use

Yes

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 Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 6.2 Inch FDA UDI
Width — 2.9 Inch FDA UDI
Height — 2.7 Inch FDA UDI

Category: Non-fixed medical gas cylinder regulator

SmartDose Evolution by Inovo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-fixed medical gas cylinder regulator.

Cleared under the same submission

K103392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inovo, Inc.

Sources (1)

  • FDA UDI 52da6f99-676e-4192-aa8a-1a6c05fe6c32 37 fields · synced May 30, 2026