FDA.reportPublic FDA data

Critikit™

Primary DI
20884450557109
Brand
Critikit™
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450557102
Catalog number
689784/A
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRBPROBE, THERMODILUTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRBProbe, ThermodilutionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K936182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K936182000CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical1994-03-25KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450557109PackageGS14In Commercial Distribution
10884450557102PrimaryGS10
00884450557105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445055710920884450557109
1088445055710210884450557102
00884450557105008844505571058844505571050884450557105

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
5
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
10884450321505Careflow™10884450321505681631/A2022-09-20
10884450321567Careflow™108844503215672018-07-19
10884450321598Careflow™108844503215982018-07-19
10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
10884450322564Meritrans DTXPlus®108844503225642018-01-26
10884450323905Critiflo™108844503239052018-01-30
10884450326463Merit Medical®108844503264632018-01-26
10884450360467Merit Medical®108844503604672018-08-06
10884450360474Merit Medical®108844503604742018-12-13
10884450360481Merit Medical®108844503604812018-09-10
10884450360498Merit Medical®108844503604982018-03-19
10884450360504Merit Medical®108844503605042018-05-22
10884450360511Merit Medical®108844503605112018-09-17
10884450360535Meritrans DTXPlus®108844503605352018-12-03
10884450360689Meritrans DTXPlus®108844503606892018-02-14
10884450360702Meritrans DTXPlus®108844503607022018-11-06
10884450360764Meritrans DTXPlus®108844503607642018-04-11
10884450360825Meritrans DTXPlus®108844503608252018-05-01
10884450371753Meritrans DTXPlus®108844503717532019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483551664Safewedge(TM) Relief Valve DeviceBIOPTIMAL INTERNATIONAL PTE. LTD.KRB2026-05-20
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKRB2026-04-15
27325710011144ITS HousingMaquet Critical Care ABKRB2026-03-24
27325710011601PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017047PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017061PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017092PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017108PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710011140ITS HousingMaquet Critical Care ABKRB2026-03-24
07325710011607PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017043PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017067PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017098PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017104PiCCO catheterMaquet Critical Care ABKRB2026-03-24
00690103000078CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
50690103000073CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyKRB2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyKRB2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyKRB2023-04-19
00195278524089NAGE Healthcare Finland OyKRB2023-04-19
00810123205080Adler Instrument CompanyAdler, Inc.KRB2023-03-03
00840682146111CARESCAPE B650GE Healthcare Finland OyKRB2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyKRB2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyKRB2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840619043636ICU MedicalICU MEDICAL, INC.KRB2021-10-19