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Drivemedical

FDA UDI

Class II (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
DRIVEMEDICAL FDA UDI
Generic Name
Suction/irrigation tubing, single-use FDA UDI
Device Name
RespiratorySuction Product Description: Carrying Case for Ped Suct MQ1200 1/ea FDA UDI
Model / Reference
MQ1200C FDA UDI
Description
RespiratorySuction Product Description: Carrying Case for Ped Suct MQ1200 1/ea FDA UDI

Identifiers

Primary DI / UDI-DI
00822383538648 FDA UDI
510(k) Number
K031413 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Suction/irrigation tubing, single-use 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

Drivemedical 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 1d964fe0-157c-4e70-9e8d-389d64293c0a 35 fields · synced Jun 8, 2026