CARPEDIEM

Primary DI
08051684580151
Brand
CARPEDIEM
Company
MOZARC MEDICAL ITALY SRL
Model
IB7010250
Device description
CARPEDIEM
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIRPediatric Hemodialysis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIRPediatric Hemodialysis SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180055000CARPEDIEM SystemBellco Srl (Now Part of Medtronic, Inc)2020-04-29QIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051684580151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051684580151080516845801518051684580151

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutionalAn assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Weight0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
508970955
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051684580090CARPEDIEMIB05955802026-07-30
080516845801133 L NON STERILE WASTE BAGSIB05070092026-07-30
08051684580083CARPEDIEMIB0595570IB05955702026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051684580090CARPEDIEMMOZARC MEDICAL ITALY SRLQIR2026-07-30
08051684580083CARPEDIEMMOZARC MEDICAL ITALY SRLQIR2026-07-29
08051736007476CARPEDIEMBELLCO SRLQIR2025-05-09
08032979792282CARPEDIEMBELLCO SRLQIR2020-06-17
08032979792299CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792290CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792283CARPEDIEMBELLCO SRLQIR2020-06-17
08051736003652CARPEDIEMBELLCO SRLQIR2020-05-20