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Front Range RX

FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
Front Range RX FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
MEDNEB+ w/Reusable Neb Cup 1/ea, 8/cv FDA UDI
Model / Reference
MQ5700-FRONT FDA UDI
Description
MEDNEB+ w/Reusable Neb Cup 1/ea, 8/cv FDA UDI

Identifiers

Primary DI / UDI-DI
00822383567297 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

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

Front Range RX 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 cfc45cec-66af-4a6b-96e8-73585a55cd59 35 fields · synced Jun 8, 2026