FDA.reportPublic FDA data

NA

Primary DI
07332414075828
Brand
NA
Company
GAMBRO DASCO SPA
Model
6033765
Catalog number
107650
Device description
SP 418 (9L Bag) Accessory Drain Bag
Published
2021-07-30
Public version status
Update
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
37332414075829PackageGS130In Commercial Distribution
07332414075828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241407582937332414075829
07332414075828073324140758287332414075828

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume9Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minimum temperature of use 20 degree Celsius
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
428788780
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
07332414121594NA - NA1159591159592025-01-30
37332414121595NA - NA1159591159592025-01-30
07332414004699NA6431233B1013542016-10-28
07332414010867NA60380201015932016-10-28
07332414032531NA60324031020742016-10-28
07332414048914NA6432470A1057622016-05-06
07332414042035PHOENIX60230067001034532015-10-23
07332414075439NA60331121076202017-05-31
07332414044732NA60322051055512017-05-31
07332414106119EXALIS604190960419092018-11-14
07332414106126EXALIS1132971132972018-11-16
37332414075829NA60337651076502021-07-30
37332414004690NA6431233B1013542016-10-28
37332414010868NA60380201015932016-10-28
37332414032532NA60324031020742016-10-28
37332414044733NA60322051055512017-05-31
37332414048915NA6432470A1057622016-05-06
37332414075430NA60331121076202017-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060497260221Clinic Water CartQUANTA DIALYSIS TECHNOLOGIES LIMITEDMON2026-06-11
07332414118914AUTO EFFLUENT SETGAMBRO UF SOLUTIONS, INCMON2025-08-18
57332414118919AUTO EFFLUENT SETGAMBRO UF SOLUTIONS, INCMON2025-08-18
07332414121594NA - NAGAMBRO DASCO SPAMON2025-01-30
37332414121595NA - NAGAMBRO DASCO SPAMON2025-01-30
05060497260078Home Water CartQUANTA 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 CartQUANTA DIALYSIS TECHNOLOGIES LIMITEDMON2021-09-27
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