CombiSet 03-2962-3

GUDID 10840861100337

Pre-pump, 8.0 mm, Home Hemo with prime bag

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use
Primary Device ID10840861100337
NIH Device Record Keydfa1938b-6959-4afd-bba1-3e4ba2217ab2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCombiSet
Version Model Number03-2962-3
Catalog Number03-2962-3
Company DUNS958291411
Company NameFresenius Medical Care Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-5188
Emailxxx@xxx.xxx

Device Dimensions

Total Volume134 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861100330 [Primary]
GS110840861100337 [Package]
Contains: 00840861100330
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONWHemodialysis system for home use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2015-09-24

On-Brand Devices [CombiSet]

10840861100474Pre-pump, 8.0 mm, BVM
10840861100337Pre-pump, 8.0 mm, Home Hemo with prime bag
10840861100320Pre-pump, 8.0 mm
10840861100306Pre-pump, 8.0 mm
10840861100290Pre-pump, 8.0 mm
108408611002838.0 mm, single needle
10840861100269Pre-pump, 6.35 mm, low volume
10840861100252Post-pump, 6.35 mm
10840861100245Pre-pump, 6.35 mm
10840861100238Pre-pump, 8.0 mm
10840861100221Post-pump, 8.0 mm
1084086110240903-2522-1

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