FDA.reportPublic FDA data

Exacta™

Primary DI
10884450321048
Brand
Exacta™
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450321048
Catalog number
680126/A
Published
2019-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450321045PackageGS110In Commercial Distribution
10884450321048PrimaryGS10
00884450321041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032104520884450321045
1088445032104810884450321048
00884450321041008844503210418844503210410884450321041

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

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

Regulatory Flags#

DUNS number
595138793
Device count
5
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
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07