FDA.reportPublic FDA data

CombiSet

Primary DI
00840861100330
Brand
CombiSet
Company
Fresenius Medical Care Holdings, Inc.
Model
03-2962-3
Catalog number
03-2962-3
Device description
Pre-pump, 8.0 mm, Home Hemo with prime bag
Published
2015-09-24
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
ONWHemodialysis system for home use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONWHemodialysis System For Home UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070049000FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America2011-02-03ONW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100337PackageGS124In Commercial Distribution
00840861100330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110033710840861100337
00840861100330008408611003308408611003300840861100330

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume134Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
958291411
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10840861102652FX CorAL 100 DialyzerF000092182024-02-23
10840861102669FX CorAL 120 DialyzerF000092192024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008408611009412008® Series Hemodialysis MachinesFresenius Usa, Inc.ONW2015-09-24
008408611009582008® Series Hemodialysis MachinesFresenius Usa, Inc.ONW2015-09-24
008408611009652008® Series Hemodialysis MachinesFresenius Usa, Inc.ONW2015-09-24
00840861101023WetAlert™ wireless wetness detectorFresenius Usa, Inc.ONW2015-09-24
10840861100337CombiSetFresenius Medical Care Holdings, Inc.ONW2015-09-24