CARPEDIEM

Primary DI
08051684580083
Brand
CARPEDIEM
Company
MOZARC MEDICAL ITALY SRL
Model
IB0595570
Catalog number
IB0595570
Device description
BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM
Published
2026-07-29
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
true

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
38051684580084PackageGS14In Commercial Distribution
08051684580083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3805168458008438051684580084
08051684580083080516845800838051684580083

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis/haemofiltration system component setA collection of sterile devices, which includes a dialyser, intended to be integrated within a system for haemodialysis and haemofiltration to treat acute or chronic renal failure by removing toxins and/or replacing electrolytes in blood; it may also be used in the treatment of fluid overload (hypervolemia). In addition to the dialyser the set includes an array of tubing and connectors, and is intended to be connected to the system pump/monitor; it is intended to be used in the home and healthcare settings. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid direct sunlight
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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08051684580151CARPEDIEMIB70102502026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051684580090CARPEDIEMMOZARC MEDICAL ITALY SRLQIR2026-07-30
08051684580151CARPEDIEMMOZARC MEDICAL ITALY SRLQIR2026-07-30
08051736007476CARPEDIEMBELLCO SRLQIR2025-05-09
08032979792282CARPEDIEMBELLCO SRLQIR2020-06-17
08032979792299CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792290CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792283CARPEDIEMBELLCO SRLQIR2020-06-17
08051736003652CARPEDIEMBELLCO SRLQIR2020-05-20