FDA.reportPublic FDA data

Phantom

Primary DI
00851314007014
Brand
Phantom
Company
Innovative Med
Model
2540-1
Catalog number
IM-K2540-1
Device description
Surgical Aspirator: 1/3 hp. 0-3.6 scfm / 0-27.5 in. hg. @ sea level, 115 VAC
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K895761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895761000GENERAL ASPERATORKolster Methods1989-10-18JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851314007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851314007014008513140070148513140070140851314007014

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction systemAn assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
928308407
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851314007434EvulseLTM-Evu S 1500PG-MBOOST-15002021-06-02
00851314007465EvulseLTM-Evu S 1000PG-MBOOST-10002021-06-02
00851314007489EvulseLTM-Evu D 5-152021-06-02
00851314007472EvulseLTM-Evu S 500PG-MBOOST-5002021-06-02
00851314007519A.T.T.SIM-ATTS-C2-EXT2024-08-21
00851314007557A.T.T.S.IM-ATTS-C2LD-SS2025-01-15
00851314007502A.T.T.SIM-ATTS-CS-D2024-08-21
00851314007076A.T.T.S.ATTS-C2IM-ATTS-C22016-09-09
00851314007083A.T.T.SATTS-C75IM-ATTS-C752016-09-12
00851314007007Phantom2550-2IM-K2550-22016-09-19
00851314007038Phantom2540-2IM-K2540-22016-09-19
00851314007045Phantom2550-1IM-K2550-12016-09-19
00851314007052K-Pump1000-0031IM-1000-00312016-09-12
00851314007212KMI IMI Group19-00992017-07-18
00851314007410A.T.T.S SILO19-79002020-05-19
00851314007397A.T.T.SATTS-C2LD-DIM-ATTS-C2LD-D2020-03-06
00851314007403A.T.T.SATTS-C2-BDIM-ATTS-C2-BD2020-03-06
00851314007281A.T.T.S.IM-FI2019-02-04
00851314007205KMI IMI GROUPSFRT2017-07-03
10851314007431EvulseLTM-Evu S 15002021-06-02

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