FDA.reportPublic FDA data

CombiSet

Primary DI
10840861100337
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
OTC
false
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

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
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
00840861100330CombiSetFresenius Medical Care Holdings, Inc.ONW2015-09-24
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