FDA.reportPublic FDA data

CARPEDIEM

Primary DI
08032979792282
Brand
CARPEDIEM
Company
BELLCO SRL
Model
IB0595570
Device description
BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38032979792283PackageGS14In Commercial Distribution
08032979792282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803297979228338032979792283
08032979792282080329797922828032979792282

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid direct sunlight
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
338685723
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08051736007476CARPEDIEMIB70102502025-05-09
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
08051736007476CARPEDIEMBELLCO SRLQIR2025-05-09
08032979792299CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792290CARPEDIEMBELLCO SRLQIR2020-06-17
38032979792283CARPEDIEMBELLCO SRLQIR2020-06-17
08051736003652CARPEDIEMBELLCO SRLQIR2020-05-20