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MicroAire®

FDA UDI

Class II (US FDA UDI)

by MicroAire Surgical Instruments LLC

Identity

Trade Name
MicroAire® FDA UDI
Generic Name
Surgical irrigation pump FDA UDI
Device Name
PAL® Infiltration Pump FDA UDI
Model / Reference
INF-PUMP FDA UDI
Description
PAL® Infiltration Pump FDA UDI

Identifiers

Primary DI / UDI-DI
00847399016645 FDA UDI
510(k) Number
K220318 FDA UDI
FDA Product Code
QPB FDA UDI
GMDN Term
Surgical irrigation pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5040 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

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

Category: Surgical irrigation pump

MicroAire® by MicroAire Surgical Instruments LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation pump.

Cleared under the same submission

K220318 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroAire Surgical Instruments LLC

Sources (1)

  • FDA UDI 8c6b35f8-4ee6-4654-88ec-543fdd684e75 34 fields · synced Jun 9, 2026