FDA.reportPublic FDA data

CombiSet

Primary DI
10840861100474
Brand
CombiSet
Company
Fresenius Medical Care Holdings, Inc.
Model
03-2795-7
Catalog number
03-2795-7
Device description
Pre-pump, 8.0 mm, BVM
Published
2015-09-30
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
K120823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120823000BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFresenius Medical Care North America, Design Cente2012-06-15FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100474PackageGS124In Commercial Distribution
00840861100477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110047410840861100474
00840861100477008408611004778408611004770840861100477

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume151Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-5188xxx@xxx.xxx

Regulatory Flags#

DUNS number
958291411
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04039361273590multiFluxF000131232026-09-29
04039361273613multiFluxF000131242026-09-29
00840861100774stay.safe®050-950032015-10-02
00840861101955NaturaLyte08-4112-208-4112-22015-10-02
10840861100542Fresenius04-9500-204-9500-22015-09-30
20840861100549Fresenius04-9500-204-9500-22015-09-30
008408611020822008T BlueStar Hemodialysis Machine1911242018-05-23
008408611020992008T BlueStar Hemodialysis Machine1911262018-05-23
008408611021052008T BlueStar Hemodialysis Machine1911282018-05-23
008408611021122008T BlueStar Hemodialysis Machine1911302018-05-23
00840861101122Crit-Line®CL100510012016-11-17
00840861101139Crit-Line®CL100410012016-11-17
00840861102068Liberty® Select Cycler1803432018-02-26
00840861102631FX CorAL 60 DialyzerF000092162024-02-23
00840861102655FX CorAL 100 DialyzerF000092182024-02-23
00840861102662FX CorAL 120 DialyzerF000092192024-02-23
00840861102679FX CorAL 600 DialyzerF000092202024-02-23
00840861102686FX CorAL 800 DialyzerF000092212024-02-23
00840861102693FX CorAL 1000 DialyzerF000092222024-02-23
10840861102638FX CorAL 60 DialyzerF000092162024-02-23

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