FDA.reportPublic FDA data

Cartridge Blood Set

Primary DI
07332414112394
Brand
Cartridge Blood Set
Company
Gambro Renal Products, S.A. de C.V.
Model
114434
Catalog number
114434
Device description
The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. The 75 ml volume models are used when a low extracorporeal blood volume is recommended.
Published
2015-10-23
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
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
37332414112395PackageGS115In Commercial Distribution
07332414112394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241411239537332414112395
07332414112394073324141123947332414112394

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
Special Storage Condition, Specify00The blood transport system must be stored in a dry place
Storage Environment Temperature-18 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
812560399
Device count
1
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
07332414112400Cartridge Blood Set1144351144352015-10-23
07332414055189Recirculation Adapter/Priming Connector1062831062832015-10-23
07332414007812Cartridge Blood Set1062891062892015-10-23
07332414007836Cartridge Blood Set1010251010252015-10-23
07332414007867Cartridge Blood Set1034011034012015-10-23
07332414007881Cartridge Blood Set1012901012902015-10-23
07332414046835Cartridge Blood Set1034021034022015-10-23
07332414085216Cartridge Blood Set1095361095362015-10-23
37332414007813Cartridge Blood Set1062891062892015-10-23
37332414007837Cartridge Blood Set1010251010252015-10-23
37332414007868Cartridge Blood Set1034011034012015-10-23
37332414007882Cartridge Blood Set1012901012902015-10-23
37332414046836Cartridge Blood Set1034021034022015-10-23
37332414055180Recirculation Adapter/Priming Connector1062831062832015-10-23
37332414085217Cartridge Blood Set1095361095362015-10-23
37332414112395Cartridge Blood Set1144341144342015-10-23
37332414112401Cartridge Blood Set1144351144352015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
06948082700729DORABain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-05-13
04711552764666SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-24
04711552760026SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552761498SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764758SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
008408611025185008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025255008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025325008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025565008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025635008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026005008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026245008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
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
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00860008016904Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
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00860008016928Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16