FDA.reportPublic FDA data

CARPEDIEM

Primary DI
08051736007476
Brand
CARPEDIEM
Company
BELLCO SRL
Model
IB7010250
Device description
CARPEDIEM
Published
2025-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08051736007476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051736007476080517360074768051736007476

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
Height67Centimeter
Length118Centimeter
Weight40Gram
Width57Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
338685723
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032979792282CARPEDIEMIB05955702020-06-17
08032979792299CARPEDIEMIB05955802020-06-17
080517360037683 L NON STERILE WASTE BAGSIB05070092021-05-30
08051736004130CLEARUM HSIBP43702021-01-01
08051736004147CLEARUM HSIBP43712021-01-01
08051736004154CLEARUM HSIBP43722021-01-01
08051736004161CLEARUM HSIBP43732021-01-01
08051736004178CLEARUM HSIBP43742021-01-01
08051736003652CARPEDIEMIB70102502020-05-20
68051736007041CLEARUM HSIBP43822023-08-04
380517360037693 L NON STERILE WASTE BAGSIB05070092021-05-30
38032979792290CARPEDIEMIB05955802020-06-17
38032979792283CARPEDIEMIB05955702020-06-17
68051736004132CLEARUM HSIBP43702021-01-01
68051736004149CLEARUM HSIBP43712021-01-01
68051736004156CLEARUM HSIBP43722021-01-01
68051736004163CLEARUM HSIBP43732021-01-01
68051736004170CLEARUM HSIBP43742021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032979792282CARPEDIEMBELLCO SRLQIR2020-06-17
08032979792299CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792290CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792283CARPEDIEMBELLCO SRLQIR2020-06-17
08051736003652CARPEDIEMBELLCO SRLQIR2020-05-20