Indigo

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name: Indigo FDA UDI
Generic Name: Surgical irrigation/aspiration pump, reusable FDA UDI
Device Name: Ind Engine Canister Assembly, CE FDA UDI
Model / Reference: IAPS3 FDA UDI
Description: Ind Engine Canister Assembly, CE FDA UDI

Identifiers

Primary DI / UDI-DI: 00814548019765 FDA UDI
510(k) Number: K180105 FDA UDI
K180412 FDA UDI
FDA Product Code: QEW FDA UDI
DXE FDA UDI
GMDN Term: Surgical irrigation/aspiration pump, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation/aspiration pump, reusable

Indigo by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180105 also covers:

Indigo Aspiration System — PENUMBRA, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Penumbra, Inc.

Sources (1)

FDA UDI b9072a3a-cf2d-41b7-89a6-f48e7f11ad6d 34 fields · synced May 30, 2026