Quelimmune

Primary DI
G62102100601
Brand
Quelimmune
Company
SEASTAR MEDICAL INCORPORATED
Model
02-1006-01
Catalog number
02-1006-01
Device description
Clinical Kit, SCD-PED
Published
2024-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QZVPediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZVPediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney InjuryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G62102100601PrimaryHIBCC0
G621021006011Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system column, selective leukocyte adsorptionA sterile cylinder containing an adsorptive carrier (e.g., cellulose acetate beads) for the adsorption of select leukocytes (e.g., granulocytes and monocytes/macropahges and mostly excluding lymphocytes, or the reverse) during apheresis. It is placed in an extracorporeal, closed-circuit apheresis system where blood is pumped from the patient, through the cylinder, and then back to the patient devoid of select leukocytes. It is typically used to treat a leukocyte-mediated condition [e.g., chronic inflammatory diseases such as inflammatory bowel disease (IBD) or rheumatoid arthritis (RA)] or to harvest select leukocytes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
100323889
Device count
6
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G621021006011Quelimmune02-1006-0102-1006-012024-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G621021006011QuelimmuneSEASTAR MEDICAL INCORPORATEDQZV2024-05-21