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Cryptographic Module Validation Program CMVP

Certificate #4573

Details

Module Name
LifeCare PCA™ Infusion Pump
Standard
FIPS 140-2
Status
Active
Sunset Date
12/14/2025
Overall Level
1
Caveat
When operated in FIPS mode
Security Level Exceptions
  • Cryptographic Module Specification: Level 3
  • Roles, Services, and Authentication: Level 3
  • Mitigation of Other Attacks: N/A
Module Type
Hardware
Embodiment
Multi-Chip Stand Alone
Description
LifeCare PCA™ is a Patient-Controlled Analgesia Infusion System with Full IV-EHR Interoperability.With the ICU Medical LifeCare PCA patient-controlled analgesia infusion system, you can be confident you are safely delivering the right drug at the right dose to the right patient in the right concentration. As the first and only PCA system with an integrated barcode reader and full IV-EHR interoperability, LifeCare PCA offers streamlined programming.
Tested Configuration(s)
  • N/A
Approved Algorithms
AES Cert. #A2736
CKG vendor affirmed
CVL Cert. #A2736
DRBG Cert. #A2737
ECDSA Cert. #A2736
HMAC Cert. #A2736
KAS KAS-SSC Cert. #A2736, CVL Cert. #A2736
KTS AES Cert. #A2736 and HMAC Cert. #A2736; key establishment methodology provides 128 or 256 bits of encryption strength
KTS AES Cert. #A2736; key establishment methodology provides 128 or 256 bits of encryption strength
RSA Cert. #A2736
SHS Cert. #A2736
Allowed Algorithms
NDRNG
Hardware Versions
P/Ns 20837-04-07 and 20837-04-08 with components 810-04505-039 and 810-11438-018
Firmware Versions
CE v1.90.1.4 and MCU v7.4.1.3

Vendor

ICU Medical, Inc.
600 North Field Drive
Lake Forest, IL 60045
USA

Chaitanya Mattur Srinivasamurthy
chaitanya.srinivasamurthy@icumed.com
Phone: +12247062518
Fax: +12247062916
Mark Rohlwing
Mark.Rohlwing@icumed.com
Phone: +14805702097

Validation History

Date Type Lab
8/31/2023 Initial UL VERIFICATION SERVICES INC