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DeVilbiss

FDA UDI

Class II (US FDA UDI)

by DeVilbiss Healthcare LLC.

Identity

Trade Name
DeVilbiss FDA UDI
Generic Name
Airway suction catheter FDA UDI
Device Name
Homecare Suction, UK with Rechargeable Battery FDA UDI
Model / Reference
7305P-U FDA UDI
Description
Homecare Suction, UK with Rechargeable Battery FDA UDI

Identifiers

Catalog Number
7305P-U FDA UDI
Primary DI / UDI-DI
00885304002420 FDA UDI
510(k) Number
K982304 FDA UDI
FDA Product Code
JCX FDA UDI
GMDN Term
Airway suction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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

Yes

FDA UDI

DeVilbiss by DeVilbiss Healthcare LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K982304 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DeVilbiss Healthcare LLC.

Sources (1)

  • FDA UDI ae9bc4c1-cc84-464d-b888-ca6a585f31b8 38 fields · synced Jun 1, 2026