CAREline 0342501

GUDID 00840861100415

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use
Primary Device ID00840861100415
NIH Device Record Key49a4595b-9000-4438-a79a-5dd3013f5434
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAREline
Version Model Number0342501
Catalog Number0342501
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
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx

Device Dimensions

Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter
Total Volume126.3 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861100415 [Primary]
GS110840861100412 [Package]
Package: null [28 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2018-04-17

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

10840861102638 - FX CorAL 60 Dialyzer2024-03-04
10840861102652 - FX CorAL 100 Dialyzer2024-03-04
10840861102669 - FX CorAL 120 Dialyzer2024-03-04
10840861102676 - FX CorAL 600 Dialyzer2024-03-04
10840861102683 - FX CorAL 800 Dialyzer2024-03-04
10840861102690 - FX CorAL 1000 Dialyzer2024-03-04
10840861102409 - CombiSet2023-10-27
10840861102645 - FX CorAL 80 Dialyzer2023-10-12

Trademark Results [CAREline]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARELINE
CARELINE
98254173 not registered Live/Pending
Fresenius Medical Care Holdings, Inc.
2023-11-03
CARELINE
CARELINE
90669803 not registered Live/Pending
NINGBO CARELINE ELECTRIC APPLIANCE CO.,LTD.
2021-04-25
CARELINE
CARELINE
88813629 not registered Live/Pending
Fresenius Medical Care Holdings, Inc.
2020-02-27
CARELINE
CARELINE
88325358 not registered Dead/Abandoned
NINGBO CARELINE ELECTRIC APPLIANCE CO.,LTD.
2019-03-05
CARELINE
CARELINE
87733453 5613511 Live/Registered
APEX HEALTH CARE MFG., INC.
2017-12-24
CARELINE
CARELINE
87141462 not registered Live/Pending
Fresenius Medical Care Holdings, Inc.
2016-08-17
CARELINE
CARELINE
86444204 4928459 Live/Registered
Mitigate Injury Management Inc.
2014-11-04
CARELINE
CARELINE
85864826 4414472 Live/Registered
Careline Industrial
2013-03-01
CARELINE
CARELINE
85668680 4506275 Live/Registered
VTech Communications, Inc.
2012-07-03
CARELINE
CARELINE
78372495 not registered Dead/Abandoned
CareCredit LLC
2004-02-23
CARELINE
CARELINE
78058700 2754351 Dead/Cancelled
SANO BRUNO'S ENTERPRISES LTD.
2001-04-16
CARELINE
CARELINE
76614720 not registered Dead/Abandoned
Rophel International Group
2004-10-06

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