FDA.reportPublic FDA data

Adsorba Hemoperfusion cartridge

Primary DI
37332414015481
Brand
Adsorba Hemoperfusion cartridge
Company
Gambro Dialysatoren GmbH
Model
150C
Catalog number
101097
Device description
The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated charcoal. The device is f
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873643000GAMBRO ADSORBA 150CGambro, Inc.1987-12-29FLD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414015481PackageGS16In Commercial Distribution
07332414015480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241401548137332414015481
07332414015480073324140154807332414015480

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
Weight150Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Beware of freezing
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316150549
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
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
07332414015473Adsorba Hemoperfusion cartridge300C1012232016-09-24
07332414015480Adsorba Hemoperfusion cartridge150C1010972016-09-24

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
07332414015473Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
07332414015480Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414015474Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414106936MARS Monitor GAMBRO ABFLD2015-06-08
37332414106950Mars Treatment KitGAMBRO ABFLD2015-06-08