FDA.reportPublic FDA data

CAREline

Primary DI
10840861102072
Brand
CAREline
Company
Fresenius Medical Care Renal Therapies Group, LLC
Model
0450007
Catalog number
0450007
Device description
Dialyzer Holder Lock Sleeve
Published
2018-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOCACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861102072PackageGS112In Commercial Distribution
00840861102075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110207210840861102072
00840861102075008408611020758408611020750840861102075

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialyser holderA device used together with certain types of a haemodialysis system that is used to hold dialysers in order to attach the blood lines from the dialyser to the system. The device is typically made of plastic or stainless steel.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079732391
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008408611023655008X HDF Hemodialysis Blood Tubing Set03-5100-72024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber03-5100-7C2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw03-5150-22024-04-08
00840861102396CitraSure™28-0600-02024-04-04
008408611026245008X04-3000-92025-08-01
00840861103010Acid connector cpl 10L jugF500449502025-08-01
00840861103027Acid connector guide 1 GalF500449532025-08-01
00840861103058BicarbyRFP-404-W2025-12-18
00840861103065BicarbyRFP-453-W2025-12-18
00840861103072BicarbyRFP-454-W2025-12-18
00840861103089BicarbyRFP-456-W2025-12-18
00840861103096BicarbyRFP-403-W2025-12-18
00840861103102BicarbyRFP-403-G2025-12-18
00840861103119BicarbyRFP-453-G2025-12-18
00840861103126BicarbyRFP-454-G2025-12-18
10840861103055BicarbyRFP-404-W2025-12-18
10840861103062BicarbyRFP-453-W2025-12-18
10840861103079BicarbyRFP-454-W2025-12-18
10840861103086BicarbyRFP-456-W2025-12-18
10840861103093BicarbyRFP-403-W2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103696Extended Cycler Base and Filter HolderNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
24987671100621Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
04987671100658Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
B144MPC825S1Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
00840861102259CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
00840861102266CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
04987671201102BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
00842289102613Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
10842289102610Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
00865165000209HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000216HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000223HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-03
0088893702095316G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702096016G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702099117G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702100417G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04