FDA.report

TA1019M

Primary DI
00886333620883
Brand
TA1019M
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682088
Catalog number
682088
Device description
Single pack dome with mounting plate
Published
2016-09-22
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

Related Records

Contact Domains

Product Codes

CodeName
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications

CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50886333620888PackageGS1120In Commercial Distribution
00886333620883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362088850886333620888
00886333620883008863336208838863336208830886333620883

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
595138793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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20884450619289Meritrans DTXPlus®10884450619282689887/B2022-02-28
20884450619296Safedraw™10884450619299689844/B2022-02-28
20884450621152Safedraw™10884450621155689883/B2022-02-28
20884450371774Meritrans DTXPlus®10884450371777682012/B2022-02-18
10884450361037Merit Medical®00884450361030684061/A2022-01-19
20884450321885Careflow™10884450321888681718/A2022-01-10
10884450361013Merit Medical®00884450361016684045/A2020-11-13
20884450320901Critikit™10884450320904680000/A2018-01-30

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