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FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
DRIVE FDA UDI
Generic Name
Inhalation-therapy adaptor, reusable FDA UDI
Device Name
Respiratory Nebs Product Description Panda Compressor Neb 220v 1/ea, 6/cv FDA UDI
Model / Reference
MQ6003NEU FDA UDI
Description
Respiratory Nebs Product Description Panda Compressor Neb 220v 1/ea, 6/cv FDA UDI

Identifiers

Primary DI / UDI-DI
00822383541709 FDA UDI
510(k) Number
K031413 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Inhalation-therapy adaptor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Drive 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 445ee171-ed50-4c6f-a89a-522dd22ff80a 35 fields · synced Jun 8, 2026