FDA.reportPublic FDA data

TA1010ND

Primary DI
00886333620845
Brand
TA1010ND
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682084
Catalog number
682084
Device description
Single packed Dome Device
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
50886333620840PackageGS1120In Commercial Distribution
00886333620845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362084050886333620840
00886333620845008863336208458863336208450886333620845

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.

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
Manufacturing date on label
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