FDA.reportPublic FDA data

UltrafleX Quad

Primary DI
00889024465909
Brand
UltrafleX Quad
Company
DORNOCH MEDICAL SYSTEMS, INC.
Model
UL-QD500
Catalog number
UL-QD500
Published
2018-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K081047000
K123188000
K133786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081047000TRANSPOSAL ULTRA SYSTEMSDornoch Medical Systems, Inc.2008-04-29JCX
K123188000DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOCDornoch Medical Systems, Inc.2013-03-04JCX
K133786000DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LIDDornoch Medical Systems, Inc.2014-03-21JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024465909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024465909008890244659098890244659090889024465909

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/smoke waste management system suction unitA mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

Sterilization Methods#

Method table
Method
High-level Disinfectant
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com
+1(800)830-0970zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
004687018
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024355552Fluid Waste Management - ConsumablesTP-RS800TP-RS8002020-03-16
00889024465923UltrafleX QuadUL-QD500SEUL-QD500SE2016-09-23
00889024578647N/ATP-CYSTOTP-CYSTO2021-11-16
00889024355545N/ATP-RS400TP-RS4002020-09-23
00889024465961NATPDC1800TP-DC18002017-06-09
00889024465978NATPDCL2800TP-DCL28002017-06-09
00889024465947N/ATPRC1800TP-RC18002016-09-21
00889024465954N/ATPRC2800TP-RC28002016-09-21
00889024578654N/ATP-SOC600TP-SOC6002021-11-16
00889024578661N/ATP-SOC650TP-SOC6502021-11-16
00889024578678N/ATP-SOC650ETP-SOC650E2021-11-16
70889024578646N/ATP-CYSTOTP-CYSTO2021-11-16
70889024578653N/ATP-SOC600TP-SOC6002021-11-16
70889024578660N/ATP-SOC650TP-SOC6502021-11-16
70889024578677N/ATP-SOC650ETP-SOC650E2021-11-16
00846795008599Stablecut®9640040002017-02-17
00889024578685N/AUL-ST100UL-ST1002020-09-23
70889024578684N/AUL-ST100UL-ST1002020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05
10848530102576Sunset Portable Suction Machine with AC/DC Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05
04719876940124TRUVIC GeneratorTaiwan Biomaterial Company LimitedJCX2024-02-19
00840117326576Respo-O2 Homecare Suction Unit, Portable, Batter Operated Dynarex CorporationJCX2023-12-29
00050428550014CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDJCX2023-03-09
40050428550012CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDJCX2023-03-09
07613327562590NeptuneSTRYKER CORPORATIONJCX2022-12-16