FDA.reportPublic FDA data

Lifecare PCA

Primary DI
M3352083704021
Brand
Lifecare PCA
Company
ICU MEDICAL, INC.
Model
208370402
Catalog number
20837
Device description
PCA 7.X w/ MedNet
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEAPump, infusion, pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEAPump, Infusion, PcaGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143612000LifeCare PCA Infusion SystemHospira, Inc.2016-04-08MEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3352083704021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient-controlled analgesia infusion pumpA battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth11.75Inch
Height15.875Inch
Length13.125Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)241-4002TSC.Support@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193494001988ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10193494001985ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10885403517945AlarisCAREFUSION 303, INC.MEA2023-11-20
10885403516030Alaris™ PCA Module, Model 8120CAREFUSION 303, INC.MEA2023-09-18
00193494000776ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
20193494000770ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
00193494001292ambIT* PIB-PCA v1.5 System w/Male Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001308ambIT* PIB-PCA v1.5 System w/Spike Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001315ambIT* PIB/PCA Pump V1.5Avanos Medical, Inc.MEA2022-02-24
00193494000707ambIT* PIB-PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494000769ambIT* PIB*IL PumpAvanos Medical, Inc.MEA2022-02-07
00193494000813ambIT* PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494001216ambIT* KIDS PIB Pump-BlueAvanos Medical, Inc.MEA2022-02-07
00193494001384ambIT* PIB IL v 1.5Avanos Medical, Inc.MEA2022-02-07
00193494000387ambIT* Cassette - Filter, Male Neuraxial ConnectorAvanos Medical, Inc.MEA2022-01-17
10885403494291AlarisCAREFUSION 303, INC.MEA2021-09-29
00817170020376Nimbus II EpiDINFUTRONIX LLCMEA2020-09-02
00850000509078ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-08-17
B101100500PXE0Manufacturing Kit CMExpress® PumpCME AMERICA LLCMEA2020-07-08
00857595005923ambIT SUMMIT MEDICAL PRODUCTS, INC.MEA2020-05-06
00850000509023ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
00850000509030ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
15019517154986CADDICU MEDICAL, INC.MEA2020-02-28
15019517155006CADDICU MEDICAL, INC.MEA2020-02-28
15019517197112PharmGuardICU MEDICAL, INC.MEA2020-01-27
15019517165753CADDICU MEDICAL, INC.MEA2019-12-30
15019517171969CADDICU MEDICAL, INC.MEA2019-12-30
10610586026669CADDICU MEDICAL, INC.MEA2019-12-05
10610586031212CADDICU MEDICAL, INC.MEA2019-12-05
10610586031861CADDICU MEDICAL, INC.MEA2019-12-05