FDA.reportPublic FDA data

simex

Primary DI
04052262385957
Brand
simex
Company
SIMEX Medizintechnik GmbH
Model
SIMEX cuff M
Catalog number
100678-3
Device description
SIMEX cuff M suction
Published
2016-09-12
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
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141255000SIMEX SUBGLOTTIC ASPIRATION SYSTEMSimex Medizintechnik GmbH2014-09-22BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052262385957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052262385957040522623859574052262385957

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose low-vacuum suction systemAn assembly of devices designed to generate a low vacuum [typically <400 millimetre(s) of mercury (mmHg)] for a variety of clinical applications (e.g., thoracic drainage, negative pressure wound therapy, endoluminal vacuum therapy, subglottic suctioning); it may be software limited to a single intended use whereby upgrade is possible. It consists of a mains electricity (AC-powered) suction pump (which may include a rechargeable battery) with software, controls, and a pressure regulator, a collection canister(s), tubing, and bacteria filter; it may also include patient contact devices. The low vacuum level is intended to reduce the risk of trauma.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure82.5 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49742092040info@simexmed.de

Regulatory Flags#

DUNS number
344498415
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260160094295FloSureFloSure Ventilation Patch1005202016-09-24
04052262385551simexSIMEX300100687-32016-09-12
04052262385568simexSIMEX200100694-32016-09-12
04052262385964simexSIMEX cuff S100679-32016-09-12
14260160094292FloSureFloSure Ventilation Patch1005202016-09-24
04052262076725simexsuction tube 50 cm1122012016-09-19
04052262413513simexsuction tube CH211122032016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978731720075Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720082Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720099Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720105Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06970289030866foreverlittleHetaida Technology Co., LtdBTA2026-07-28
00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
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00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
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00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26