FDA.reportPublic FDA data

CRITIFLO(TM) TAK0460

Primary DI
00886333621187
Brand
CRITIFLO(TM) TAK0460
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682118
Catalog number
682118
Device description
"60 drops, 60"" tube length AdSet packed together with a Critiflo connected with a 48"" & 12"" pressure Tubing and stopcock"
Published
2016-09-25
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
50886333621182PackageGS150In Commercial Distribution
00886333621187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362118250886333621182
00886333621187008863336211878863336211870886333621187

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524809TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524847TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524946TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525462TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525486TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403527411TruWaveBecton, Dickinson And CompanyDXO2026-05-30
07460691952775TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
00690103210828Combo KitsEdwards Lifesciences LLCDXO2025-07-15
07460691925298TRUWAVE/VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691925731TRUWAVE X 2 (3 CC) /VAMP 98 IN (250 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691926769TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691930179TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691948990TRUWAVE X 2 (3 CC) /VAMP 86 IN (220 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949003TRUWAVE (3 CC) /VAMP 88 IN (225 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691949553TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691924840TRUWAVE X 3 (3 CC) /VAMP 75 IN (190 CM)Edwards Lifesciences LLCDXO2024-09-04
07460691924956TRUWAVE, VAMP JREdwards Lifesciences LLCDXO2024-09-04
07460691947221TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947245TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691947467TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-04
07460691949287TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)Edwards Lifesciences LLCDXO2024-09-04
00852004007208Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007222Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No GuidewireENDOPHYS HOLDINGS, LLCDXO2024-02-29
00852004007031Endophys Pressure Sensing Sheath Kit - 8F 11 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007062Endophys Pressure Sensing Sheath Kit - 6F 12 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
00852004007079Endophys Pressure Sensing Sheath Kit - 8F 25 CMENDOPHYS HOLDINGS, LLCDXO2023-10-27
10888277804128Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXO2023-07-29