FDA.reportPublic FDA data

Exacta™

Primary DI
20884450321052
Brand
Exacta™
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450321055
Catalog number
680128/A
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941428000EXACTA PERCUTANEOUS INTRODUCER SHEATHOhmeda Medical1994-07-06DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450321052PackageGS110In Commercial Distribution
10884450321055PrimaryGS10
00884450321058Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032105220884450321052
1088445032105510884450321055
00884450321058008844503210588844503210580884450321058

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
5
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27