FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709082717
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
ESP-60S
Catalog number
ESP-60S
Device description
ESP-60cc version
Published
2021-10-26
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
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914988000500 INFUSERExcel Medical, Inc.1992-04-06FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887709082717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887709082717008877090827178877090827170887709082717

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical fluid-dispensing systemA assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22
10887709207162BivonaFT26JN50NSF156N2026-10-22
10887709207179BivonaFT26JN65NSC160N2026-10-22
10887709207193BivonaFT26JN60NSC164N2026-10-22
10887709207209BivonaFT26JN35NGF165N2026-10-22
10887709207216BivonaAT26JS35NSA151N2026-10-22
10887709207223BivonaAT26JS40NSA150N2026-10-22
10887709207032BivonaFT26JN30NGE149N2026-10-21
10887709207049BivonaFT26JN35NGE148N2026-10-21
10887709207056BivonaFT26JN40NGE145N2026-10-21
10887709207063BivonaXU26JS50NSC147N2026-10-21
10887709207070BivonaFT26IN40NSF242N2026-10-21
10887709207087BivonaFU26JN60NGA155N2026-10-21
10887709207094BivonaFU26JN40NGF146N2026-10-21
10887709206905BivonaFU26JN40NSC136N2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403532948BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-22
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20