FDA.reportPublic FDA data

Adsorba Hemoperfusion cartridge

Primary DI
07332414015473
Brand
Adsorba Hemoperfusion cartridge
Company
Gambro Dialysatoren GmbH
Model
300C
Catalog number
101223
Device description
The Adsorba 300C hemoperfusion cartridge is a steam sterilized device which contains 300 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLDApparatus, hemoperfusion, sorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLDApparatus, Hemoperfusion, SorbentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414015474PackageGS16Not in Commercial Distribution
07332414015473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241401547437332414015474
07332414015473073324140154737332414015473

GMDN Terms#

Term, Definition table
TermDefinition
Haemoperfusion system absorption columnA sterile container that is a component of a haemoperfusion system used for the removal of toxins from a patient's blood, and that holds materials (e.g., activated carbon or resins) which absorb (adsorb) a specific toxin or range of toxins. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight300Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
316150549
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414102500Ultrafilter U 90001120621120622021-03-31
07332414126957U9000 Plus ultrafilter9558259558252021-12-30
07332414031770POLYFLUX17R1017852015-10-12
07332414031787POLYFLUX21R1006912015-10-12
07332414036140POLYFLUX24R1043242015-10-12
07332414036416Polyflux17L1020582015-10-08
07332414036423Polyflux14L1020572015-10-12
07332414037925Polyflux140H1035302015-10-12
07332414037932Polyflux170H1035792015-10-12
07332414041465POLYFLUX6LR1043292015-10-12
07332414041472POLYFLUX8LR1043332015-10-12
07332414047108POLYFLUX10LR1043112015-10-12
07332414048181Polyflux21L1041762015-10-12
07332414048198Polyflux210H1035802015-10-12
07332414114916Revaclear3001147452015-10-12
07332414114923Revaclear4001147462015-10-12
07332414126193REVACLEARRevaclear 300114745M2021-11-08
07332414126209REVACLEARRevaclear 400114746M2021-11-08
07332414015480Adsorba Hemoperfusion cartridge150C1010972016-09-24
07332414036386Polyflux6H1034032015-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
37332414107728MARS TREATMENT KIT TYPE 1116/1 - X-MARS USGAMBRO ABFLD2017-10-26
07332414015480Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414015474Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414015481Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414106936MARS Monitor GAMBRO ABFLD2015-06-08
37332414106950Mars Treatment KitGAMBRO ABFLD2015-06-08