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Nimbus

FDA UDI

Class II (US FDA UDI)

by Infutronix Llc

Identity

Trade Name
Nimbus FDA UDI
Generic Name
Patient-controlled analgesia infusion pump FDA UDI
Device Name
This is a plastic box outside a drug bag less than or equal to 100ml. FDA UDI
Model / Reference
Nimbus Hard Shell 100ml FDA UDI
Description
This is a plastic box outside a drug bag less than or equal to 100ml. FDA UDI

Identifiers

Primary DI / UDI-DI
00817170020154 FDA UDI
510(k) Number
K153193 FDA UDI
FDA Product Code
MEA FDA UDI
FRN FDA UDI
GMDN Term
Patient-controlled analgesia infusion pump 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ambulatory non-insulin infusion pump, electronicPatient-controlled analgesia infusion pump

Nimbus by Infutronix Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient-controlled analgesia infusion pump.

Cleared under the same submission

K153193 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Infutronix Llc

Sources (1)

  • FDA UDI 7479b77b-628b-4904-b6ed-5306400ba2c1 34 fields · synced Jun 6, 2026