FDA.reportPublic FDA data

Medline

Primary DI
40080196769293
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
HCS7000
Catalog number
HCS7000
Device description
ASPIRATOR,SUCTION,W/800CC CANISTER
Published
2021-07-14
Public version status
New
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
K042349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042349000EMG MODEL SUA01 SUCTION UNITEmg Technology Co., Ltd.2004-12-16JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196769293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019676929340080196769293

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

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