FDA.reportPublic FDA data

AUTO EFFLUENT SET

Primary DI
07332414118914
Brand
AUTO EFFLUENT SET
Company
GAMBRO UF SOLUTIONS, INC
Model
115370
Catalog number
115370
Device description
The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining during Continuous Renal Replacement Therapy (CRRT).
Published
2025-08-18
Public version status
New
Distribution status
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
MONSYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MONSystem, Hemodialysis, Remote AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414118919PackageGS18In Commercial Distribution
07332414118914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5733241411891957332414118919
07332414118914073324141189147332414118914

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal circuit waste bagA flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume6Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)525-2623Us.RENAL.Support.Co@vantive.com

Regulatory Flags#

DUNS number
132629788
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57332414118919AUTO EFFLUENT SET1153701153702025-08-18
07332414112370Blood Circuit SetUF 500-HCT1141572015-09-29
07332414112387Blood Circuit SetUF 5001141562015-09-29
07332414112301Aquadex FlexFlow1141581141582015-10-07
07332414112264NA1144231144232018-09-28
07332414112363Dual Lumen Extended Length Catheter1141531141532015-10-12
07332414119324Dual Lumen Extended Length Catheter and GALT insertion kit1154631154632015-10-12
57332414112269NA1144231144232018-09-28
27332414112367Dual Lumen Extended Length Catheter1141531141532015-10-12
37332414112371Blood Circuit SetUF 500-HCT1141572015-09-29
37332414112388Blood Circuit SetUF 5001141562015-09-29
37332414119325Dual Lumen Extended Length Catheter and GALT inser1154631154632015-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
57332414118919AUTO EFFLUENT SETGAMBRO UF SOLUTIONS, INCMON2025-08-18
07332414121594NA - NAGAMBRO DASCO SPAMON2025-01-30
37332414121595NA - NAGAMBRO DASCO SPAMON2025-01-30
05060497260078Home Water Cart QUANTA DIALYSIS TECHNOLOGIES LIMITEDMON2023-01-05
B144MPC14171Molded Products, Inc.MOLDED PRODUCTS, INC.MON2022-10-04
B144MPC14152Molded Products, Inc.MOLDED PRODUCTS, INC.MON2022-08-03
B144MPC14202Molded Products, Inc.MOLDED PRODUCTS, INC.MON2022-08-03
05060497260061Clinic Water Cart QUANTA DIALYSIS TECHNOLOGIES LIMITEDMON2021-09-27
07332414075828NAGAMBRO DASCO SPAMON2021-07-30
37332414075829NAGAMBRO DASCO SPAMON2021-07-30
00858293006885Spiral Coil Tubing, ClearREPROCESSING PRODUCTS CORPORATIONMON2021-05-17
00858293006892Spiral Coil Tubing, Trans RedREPROCESSING PRODUCTS CORPORATIONMON2021-05-17
00858293006908Spiral Coil Tubing, Trans BlueREPROCESSING PRODUCTS CORPORATIONMON2021-05-17
00858293006861Sani-lok Blood Port Barrier AdaptorREPROCESSING PRODUCTS CORPORATIONMON2021-05-13
00858293006878Sani-lok Blood Port Barrier AdaptorREPROCESSING PRODUCTS CORPORATIONMON2021-05-13
00858293006847E-Z Draw Sample PortREPROCESSING PRODUCTS CORPORATIONMON2021-04-06
00858293006359E-Z DrawREPROCESSING PRODUCTS CORPORATIONMON2020-10-13
00858293006830E-Z DrawREPROCESSING PRODUCTS CORPORATIONMON2020-10-13
04046955348923Streamline Dialyzer HolderB. BRAUN MEDICAL INC.MON2020-08-07
04046955348916Streamline Dialyzer HolderB. BRAUN MEDICAL INC.MON2020-08-07
B144MPC1400B2Molded Products, Inc.MOLDED PRODUCTS, INC.MON2019-09-04
B144MPC14052Molded Products, Inc.MOLDED PRODUCTS, INC.MON2019-09-04
B144MPC7901Molded Products, Inc.MOLDED PRODUCTS, INC.MON2019-09-04
00858293006458Luer Fitting FemaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006465Luer Fitting MaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006755Pump Spring, WeakREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006762Pump Spring, StrongREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
10858293006455Luer Fitting FemaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
10858293006462Luer Fitting MaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006472GuageREPROCESSING PRODUCTS CORPORATIONMON2019-08-30