← Back to catalogue

Drive

FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
Drive FDA UDI
Generic Name
Medicine chamber spacer, reusable FDA UDI
Device Name
Large Mask for MQ8000 FDA UDI
Model / Reference
MQ80L FDA UDI
Description
Large Mask for MQ8000 FDA UDI

Identifiers

Primary DI / UDI-DI
00822383539386 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Medicine chamber spacer, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medicine chamber spacer, reusable

Drive by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medicine chamber spacer, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA UDI b28ffbe2-5c8e-4a2e-8bf9-f8581c7d1987 33 fields · synced Jun 6, 2026