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Alaris™ Guardrails™ Editor Software Kit, Model 8961

FDA UDI

Class II (US FDA UDI)

by CareFusion 303, INC

Identity

Trade Name
Alaris™ Guardrails™ Editor Software Kit, Model 8961 FDA UDI
Generic Name
Infusion pump medication-dosage application software FDA UDI
Device Name
Alaris™ Guardrails™ Editor Software Kit, Model 8961 v12.1.3 FDA UDI
Model / Reference
8961 FDA UDI
Description
Alaris™ Guardrails™ Editor Software Kit, Model 8961 v12.1.3 FDA UDI

Identifiers

Catalog Number
49000691 FDA UDI
Primary DI / UDI-DI
10885403896125 FDA UDI
FDA Product Code
PHC FDA UDI
GMDN Term
Infusion pump medication-dosage application software 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infusion pump medication-dosage application software

Alaris™ Guardrails™ Editor Software Kit, Model 8961 by CareFusion 303, INC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infusion pump medication-dosage application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CareFusion 303, INC

Sources (1)

  • FDA UDI 9e2550c6-8387-4d2e-be8a-63b48fab52eb 35 fields · synced May 30, 2026