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Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name
Hokanson FDA UDI
Generic Name
Medical device air compressor FDA UDI
Device Name
AIR SOURCE; 110V OR 100V - An AC powered device used to create and supply compressed air to the Hokanson E20 Rapid Cuff Inflator. FDA UDI
Model / Reference
AG101 FDA UDI
Description
AIR SOURCE; 110V OR 100V - An AC powered device used to create and supply compressed air to the Hokanson E20 Rapid Cuff Inflator. FDA UDI

Identifiers

Catalog Number
00587 FDA UDI
Primary DI / UDI-DI
00817065021228 FDA UDI
510(k) Number
K905367 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Medical device air compressor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
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

No

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

Category: Medical device air compressor

Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical device air compressor.

Cleared under the same submission

K905367 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
D. E. Hokanson, Inc.

Sources (1)

  • FDA UDI 3aee16e2-fc05-4d3d-ace2-0e4945ab59a9 36 fields · synced Jun 8, 2026