FDA.reportPublic FDA data

Streamline Dialyzer Holder

Primary DI
04046955348916
Brand
Streamline Dialyzer Holder
Company
B. BRAUN MEDICAL INC.
Model
M8-2400A
Catalog number
M8-2400A
Device description
ANCILLARY-DIALYZER BRCKT ASS'Y FRESENIUS
Published
2020-08-07
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
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
04046955348923PrimaryGS10
04046955348916Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955348923040469553489234046955348923
04046955348916040469553489164046955348916

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialyser holderA device used together with certain types of a haemodialysis system that is used to hold dialysers in order to attach the blood lines from the dialyser to the system. The device is typically made of plastic or stainless steel.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
18
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
57332414118919AUTO EFFLUENT SETGAMBRO UF SOLUTIONS, INCMON2025-08-18
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
05060497260061CartQUANTA 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
00858293006878Sani-lok Blood Port Barrier AdaptorREPROCESSING PRODUCTS CORPORATIONMON2021-05-13
00858293006847E-Z Draw Sample PortREPROCESSING PRODUCTS CORPORATIONMON2021-04-06
00858293006830E-Z DrawREPROCESSING PRODUCTS CORPORATIONMON2020-10-13
10858293006455Luer Fitting FemaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
10858293006462Luer Fitting MaleREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006472GuageREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006489BulbREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006496Black Tubing, NaturalREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006502Black Tubing, PVCREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006700Spiral Tubing, Trans RedREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006717Spirial Tubing, Trans BlueREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006724Spiral Coil Tubing ClearREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006731Spiral Coil Tubing, Trans RedREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006748Spiral Coil Tubing, Trans BlueREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
10858293006752Pump Spring, WeakREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
10858293006769Pump Spring, StrongREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006779Dialyzer Dialysate QD to 45° Angle Hose Barb RedREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006786Dialyzer Dialysate QD to 45° Angle Hose Barb BlueREPROCESSING PRODUCTS CORPORATIONMON2019-08-30
00858293006793Dialyzer Dialysate QD to 3/8 in.NPTREPROCESSING PRODUCTS CORPORATIONMON2019-08-30