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

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
09551019761686VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107623VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107630VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107647VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107654VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107661VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107678VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107685VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107616VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-27
09551032478004STREAMLINEVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09551032478011STREAMLINEVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100891VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100907VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100921VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100938VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100945VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100969VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100976VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100983VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100990VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793101003VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107524VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107531VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107548VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107555VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107562VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107579VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107586VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107593VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107609VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23