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ambIT* PCA Pump

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
ambIT* PCA Pump FDA UDI
Generic Name
Ambulatory non-insulin infusion pump, electronic FDA UDI
Device Name
PCA Pump FDA UDI
Model / Reference
220262 FDA UDI
Description
PCA Pump FDA UDI

Identifiers

Catalog Number
220262 FDA UDI
Primary DI / UDI-DI
00193494000813 FDA UDI
510(k) Number
K002434 FDA UDI
FDA Product Code
MEA FDA UDI
GMDN Term
Ambulatory non-insulin infusion pump, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ambulatory non-insulin infusion pump, electronic

ambIT* PCA Pump by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory non-insulin infusion pump, electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI be5a2c26-b524-4d23-80df-cc88505bf455 36 fields · synced Jun 9, 2026