FDA.reportPublic FDA data

CRITIFLO(TM) TAK1560T

Primary DI
00886333621200
Brand
CRITIFLO(TM) TAK1560T
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682120
Catalog number
682120
Device description
"A separate 60 drops, 60"" tube Adset packs with a Critiflo dome set connected to pressure tubing and 2x 3-Way White Off stopcocks. It also includes a separately packed 2x male protective caps."
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333621205PackageGS150In Commercial Distribution
00886333621200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362120550886333621205
00886333621200008863336212008863336212000886333621200

GMDN Terms#

Term, Definition table
TermDefinition
Pressure transducer dome, single-useA sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
595138793
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
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00885403544586TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403524038TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524502TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05