FDA.reportPublic FDA data

Crono

Primary DI
08050616612007
Brand
Crono
Company
CANE' SPA
Model
S-PID 50
Device description
The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the controlled subcutaneous administration of immunoglobulin.
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K091042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091042000CRONO S-PID 50Cane S.R.L.2009-05-12FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050616612014PackageGS11In Commercial Distribution
08050616612007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050616612014080506166120148050616612014
08050616612007080506166120078050616612007

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory non-insulin infusion pump, electronicA battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.

Contacts#

Phone, Email table
PhoneEmail
(630) 845-7867rmcdowell@intrapump.com

Regulatory Flags#

DUNS number
438017964
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050616612021CronoSuper PID2017-03-21
08050616612045Cronogo2016-10-24
08050616612069CronoF2017-03-21
08050616612038CronoSuper PID2017-03-21
08050616612076CronoF2017-03-21
08050616612014CronoS-PID 502016-10-06
08050616612052Cronogo2016-10-24
08050616611512crn CRONO Syringe reservoirCRN/10/WN2017-04-11
08050616611536crn CRONO Syringe reservoirCRN/20/WN2017-04-11
08050616611550crn CRONO Syringe reservoirCRN50ML2017-04-11
08050616611635APO-GO Syringe reservoirAPO-GO/20/WN 2018-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
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
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory 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