FDA.reportPublic FDA data

Diapact®

Primary DI
04039239047315
Brand
Diapact®
Company
B. BRAUN MEDICAL INC.
Model
7210517
Catalog number
7210517
Device description
CWHD/CWHFD Tubing Set (unassembled)
Published
2015-08-09
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
FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04039239047315PrimaryGS10
04039239047308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04039239047315040392390473154039239047315
04039239047308040392390473084039239047308

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)848-2066rtd.us@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
108408611025155008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025225008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025395008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025605008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
40383790011875SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011882NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011899NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011905NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00850001011259Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-05-21
00850001011273Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-01-22
10840861102409CombiSetFresenius Medical Care Holdings, Inc.FJK2023-10-19
04046955776016Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2023-03-06
10850001011218Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
00850001011242Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
16948082709774NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
16948082709781NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
10887709021980ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709027517ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709076409ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709028019ICU MedicalICU MEDICAL, INC.FJK2021-07-27
04046955735280Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2021-07-25
05060497260016SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
05060497260030SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
37332414004096BLOOD CIRCUIT SETBAXTER HEALTHCARE CORPORATIONFJK2021-05-13
16948082702102NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15
16948082702119NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15