Quelimmune

Primary DI
G621021006011
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100323889
Device count
6
DM exempt
false
Premarket exempt
true
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
G62102100601Quelimmune02-1006-0102-1006-012024-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G62102100601QuelimmuneSEASTAR MEDICAL INCORPORATEDQZV2024-05-21