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In Home Oxygen & Medical Supply

FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
In Home Oxygen & Medical Supply FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
IHO-PedBeagleNebwReuse&DispKit, 1/ea FDA UDI
Model / Reference
18091BE-IHO FDA UDI
Description
IHO-PedBeagleNebwReuse&DispKit, 1/ea FDA UDI

Identifiers

Primary DI / UDI-DI
00822383523255 FDA UDI
510(k) Number
K031413 FDA UDI
FDA Product Code
BTI FDA UDI
CAF FDA UDI
GMDN Term
Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.6250 FDA UDI
868.5630 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

In Home Oxygen & Medical Supply by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K031413 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drive Devilbiss Healthcare

Sources (1)

  • FDA UDI e300cbb5-92af-45d1-95da-35c67663df47 35 fields · synced Jun 6, 2026