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KIRO Fill US

FDA UDI

Class II (US FDA UDI)

by Kiro Grifols Sl.

Identity

Trade Name
KIRO Fill US FDA UDI
Generic Name
Intravenous solution compounder FDA UDI
Device Name
KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations (CSPs). The device is intended to be used only by qualified pharmacy personnel. FDA UDI
Model / Reference
1002US FDA UDI
Description
KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations (CSPs). The device is intended to be used only by qualified pharmacy personnel. FDA UDI

Identifiers

Primary DI / UDI-DI
08437014572223 FDA UDI
FDA Product Code
NEP FDA UDI
GMDN Term
Intravenous solution compounder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravenous solution compounder

KIRO Fill US by Kiro Grifols Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous solution compounder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kiro Grifols Sl.

Sources (1)

  • FDA UDI de611c11-5dbf-4cd1-9429-6e9ac6deccb8 34 fields · synced May 30, 2026