FDA.reportPublic FDA data

Crit-Line®

Primary DI
10840861102027
Brand
Crit-Line®
Company
Fresenius Usa, Inc.
Model
191058
Catalog number
191058
Device description
Blood Chamber II
Published
2016-10-04
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
KOCACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160749000CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC2016-04-15KOC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861102027PackageGS136In Commercial Distribution
20840861102024PackageGS18In Commercial Distribution
00840861102020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110202710840861102027
2084086110202420840861102024
00840861102020008408611020208408611020200840861102020

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system blood volume monitorA mains electricity (AC-powered) device designed to non-invasively monitor the relative variations of the blood volume during a haemodialysis treatment. The blood is lead through a chamber in this device where measurements are taken and calculations of haematocrit (volume percent of erythrocytes), haemoglobin oxygen saturation (SpO2), and percent change in blood volume are made and displayed. In addition the monitor may estimate and display the urea reduction ration (URR) on relative changes in urea nitrogen concentration in the spent dialysate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)546-5463crit-line@fmc-na.com

Regulatory Flags#

DUNS number
076594100
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
true
Expiration date on label
true
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
00840861102280VersiPD1308312023-08-01
008408611009652008® Series Hemodialysis Machines1909042015-09-24
00840861102198VersiPD1308212023-02-14
00840861102297VersiPD1308322023-02-14
008408611008972008® Series Hemodialysis Machines1907132015-09-30
008408611009032008® Series Hemodialysis Machines1908582015-09-30
008408611009342008® Series Hemodialysis Machines1909082016-06-06
008408611009412008® Series Hemodialysis Machines1908282015-09-24
04046241091694FreseniusM528372015-10-02
04046241091700FreseniusM528362015-10-02
04046241091717FreseniusM528382015-10-02
04046241091731FreseniusM528402015-10-02
00840861102020Crit-Line®1910581910582016-10-04
00840861101023WetAlert™ wireless wetness detector1905072015-09-24
00840861100552Crit-Line®CL10041021CL100410212015-10-19
10840861100559Crit-Line®CL10041021CL100410212015-10-19
008408611008592008® Series Hemodialysis Machines1906102015-09-30
008408611008662008® Series Hemodialysis Machines1906302015-09-30
008408611008732008® Series Hemodialysis Machines1906332015-09-30
008408611009102008® Series Hemodialysis Machines1907662015-09-30

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