FDA.reportPublic FDA data

Cartridge Blood Set

Primary DI
37332414007882
Brand
Cartridge Blood Set
Company
Gambro Renal Products, S.A. de C.V.
Model
101290
Catalog number
101290
Device description
The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Published
2015-10-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070414000GAMBRO CARTRIDGE BLOOD SETSGambro Renal Products2007-10-12FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414007882PackageGS15In Commercial Distribution
07332414007881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241400788237332414007882
07332414007881073324140078817332414007881

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
812560399
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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
07332414112394Cartridge Blood Set1144341144342015-10-23
37332414007813Cartridge Blood Set1062891062892015-10-23
37332414007837Cartridge Blood Set1010251010252015-10-23
37332414007868Cartridge Blood Set1034011034012015-10-23
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

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Primary DI, Brand, Company table
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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
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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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