FDA.reportPublic FDA data

CRITIFLO(TM) TAK1760M

Primary DI
00886333621286
Brand
CRITIFLO(TM) TAK1760M
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682128
Catalog number
682128
Device description
"A separate 60 drops,60"" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48"", 3-Way White OFF stopcock and 12"" Pressure tubing. 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
50886333621281PackageGS150In Commercial Distribution
00886333621286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362128150886333621281
00886333621286008863336212868863336212860886333621286

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
10884450321031Exacta™10884450321031680124/A2021-02-16
10884450321048Exacta™10884450321048680126/A2019-05-28
10884450321055Exacta™10884450321055680128/A2019-06-03
10884450321062Exacta™10884450321062680140/A2019-07-05
10884450389994Exacta™10884450389994680132/A2019-09-04
00886333610006SECALON T 18G/1.25 X 90MM MULT=25/2506810006810002016-09-24
00886333610020SECALON T 16G/1.70 X 130MM MULT=25/2506810026810022016-09-30
00886333610044SECALON T 16G/1.70 X 160MM MULT=25/2506810046810042016-09-23
00886333616121CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816126816122016-09-24
00886333616145CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816146816142016-09-24
00886333616152CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816156816152016-09-24
00886333616169CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816166816162016-09-24
00886333616176CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816176816172016-09-24
00886333616183CAREFLOW(TM) 3 LUMEN 5FR X 100MM6816186816182016-09-24
00886333616190CAREFLOW(TM) 2 LUMEN 5FR X 60MM6816196816192016-09-24
00886333616206CAREFLOW(TM) 3 LUMEN 5FR X 60MM6816206816202016-09-24
00886333616220CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816226816222016-09-24
00886333616237CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816236816232016-09-24
00886333616244CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816246816242016-09-24
00886333616251CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816256816252016-09-24

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