FDA.reportPublic FDA data

Vascular Tubeset

Primary DI
04719876940209
Brand
Vascular Tubeset
Company
Taiwan Biomaterial Company Limited
Model
PAT10261B
Device description
Imperative Care Vascular Tubeset, PAT10261B
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190105000ZOOM Aspiration PumpTaiwan Biomaterial Co., Ltd.2019-02-21JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876940094PreviousGS10
04719876940209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876940094047198769400944719876940094
04719876940209047198769402094719876940209

GMDN Terms#

Term, Definition table
TermDefinition
Disposable surgical irrigation/aspiration systemA device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place at room temperature.

Regulatory Flags#

DUNS number
656073408
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719876940193Imperative Care PumpTAP1B2026-10-21
04719876940216Vascular CanisterPTC001B2026-10-21
04719876940186ZOOM™ Duoport CanisterTDC001B2025-02-24
04719876940124TRUVIC GeneratorPTC002B2024-02-19
04719876940094TRUVIC GeneratorPAT10261B2022-02-21
04719876940100TRUVIC GeneratorPTC001B2022-02-21
04719876940117TRUVIC GeneratorPTG1B2022-02-21
04719876940087ZOOM Aspiration PumpAFT117B2021-12-17
04719876940001ZOOM Aspiration PumpTAT102B2019-03-15
04719876940018ZOOM Aspiration PumpTAP1B2019-03-15
04719876940025ZOOM Aspiration PumpTC001B2019-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876940193Imperative Care PumpTaiwan Biomaterial Company LimitedJCX2026-10-21
04719876940216Vascular CanisterTaiwan Biomaterial Company LimitedJCX2026-10-21
00841447198086Invacare® AspiratorINVACARE CORPORATIONJCX2026-09-22
07090066940023CaryExcitus Medical ASJCX2026-07-28
00842429118689MV Flow Aspiration PumpMicrovention, Inc.JCX2026-07-15
00749756401258DeRoyalDEROYAL INDUSTRIES, INC.JCX2026-01-22
10612479280554McKessonMCKESSON MEDICAL-SURGICAL INC.JCX2025-12-03
10612479280066McKessonMCKESSON MEDICAL-SURGICAL INC.JCX2025-11-19
00763000981327Riptide Collection Canister with Intermediate TubingMicro Therapeutics, Inc.JCX2025-10-31
00763000915681Riptide™ Aspiration PumpMicro Therapeutics, Inc.JCX2025-08-18
00815067013609Roscoe MedicalDrive Devilbiss HealthcareJCX2025-08-13
04719876940186ZOOM™ Duoport CanisterTaiwan Biomaterial Company LimitedJCX2025-02-24
00092237626672Roscoe MedicalDrive Devilbiss HealthcareJCX2025-02-10
00092237626627Roscoe MedicalDrive Devilbiss HealthcareJCX2025-01-29
37613327644068NeptuneSTRYKER CORPORATIONJCX2024-12-06
07613327644067NeptuneSTRYKER CORPORATIONJCX2024-12-06
00092237626689Roscoe MedicalDrive Devilbiss HealthcareJCX2024-11-19
00885304032557DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
00885304032571DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
37613327566162NeptuneSTRYKER CORPORATIONJCX2024-10-15
00848530091293Power and AccessoriesSunset Healthcare Solutions, Inc.JCX2024-08-08
00848530091873Power and AccessoriesSunset Healthcare Solutions, Inc.JCX2024-08-08
10848530091290Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530091378Portable SuctionSunset Healthcare Solutions, Inc.JCX2024-08-08
10848530091870Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530096199Portable SuctionSunset Healthcare Solutions, Inc.JCX2024-08-08
00848530096205Closed SuctionSunset Healthcare Solutions, Inc.JCX2024-08-08
07613327634914NeptuneSTRYKER CORPORATIONJCX2024-04-16
00848530102579Sunset Portable Suction Machine with AC/DC PowerSunset Healthcare Solutions, Inc.JCX2024-03-05
10848530102576Sunset Portable Suction Machine with AC/DC Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05