FDA.reportPublic FDA data

THERANOVA

Primary DI
37332414125722
Brand
THERANOVA
Company
Gambro Dialysatoren GmbH
Model
500
Catalog number
955692
Device description
Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da -
Published
2020-10-26
Public version status
New
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
QAXHemodialyzer with expanded solute removal profile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAXHemodialyzer With Expanded Solute Removal ProfileGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190042000Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerBaxter Healthcare Corporation2020-08-28QAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414125722PackageGS124In Commercial Distribution
07332414125721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241412572237332414125722
07332414125721073324141257217332414125721

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, single-useA filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area2Square meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001medinfo_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
true
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
07332414125721THERANOVAGambro Dialysatoren GmbHQAX2020-10-26
07332414125714THERANOVAGambro Dialysatoren GmbHQAX2020-09-02
37332414125715THERANOVAGambro Dialysatoren GmbHQAX2020-09-02