FDA.reportPublic FDA data

Schuco

Primary DI
00260720011650
Brand
Schuco
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
S230A6
Device description
Aspirator
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00260720011650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720011650002607200116502607200116500260720011650

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, line-poweredAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099674145
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
true
Expiration date on label
false
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
40026072025220pc55-01-0014-KZ2023-12-11
40026072025237PC55-01-0014-RU2023-12-11
40026072025244PC55-01-00152023-12-11
40026072025251PC55-01-00162023-12-11
40026072025268PC55-01-00172023-12-11
40026072025275PC55-01-00182023-12-11
40026072025282PC55-01-00192023-12-11
40026072025305PC55-01-00252023-12-11
40026072025312PC55-01-00262023-12-11
40026072025329PC55-01-00272023-12-11
40026072025336PC55-01-00282023-12-11
00260720010523VACUTRON22-18-16082016-08-09
00260720010745Vacutron22-19-16082016-08-26
00260720009374VACUTRONMINI-VAC22-16-16082016-09-12
00260720002627Chemtron219000-2322-10-00022016-09-09
00260720002634Chemtron219000-4322-10-00042016-09-09
00260720002641Chemtron219000-03-RPL22-10-00082016-09-09
00260720011544SchucoS1160-RPLS1160-RPL2016-09-15
00260720011551SchucoS1160A-RPLS1160A-RPL2016-09-15
00260720011568SchucoS1160B-MED2S1160B-MED22016-09-15

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