FDA.reportPublic FDA data

NA

Primary DI
37332414048915
Brand
NA
Company
GAMBRO DASCO SPA
Model
6432470A
Catalog number
105762
Device description
GMB-SP127 Accessory Y connector
Published
2016-05-06
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
K801016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801016000GAMBRO G SERIES BLOOD LINE SETS FOR HEM.Gambro, Inc.1980-05-30FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414048915PackageGS125In Commercial Distribution
07332414048914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241404891537332414048915
07332414048914073324140489147332414048914

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 accessories for hemodialysis must be stored in a dry place
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
428788780
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
true
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
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
07332414075828NA60337651076502021-07-30
07332414106119EXALIS604190960419092018-11-14
07332414106126EXALIS1132971132972018-11-16
37332414075829NA60337651076502021-07-30
37332414004690NA6431233B1013542016-10-28
37332414010868NA60380201015932016-10-28
37332414032532NA60324031020742016-10-28
37332414044733NA60322051055512017-05-31
37332414075430NA60331121076202017-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860008016942Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01