FDA.reportPublic FDA data

ATMOS

Primary DI
04250365135992
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
C 451
Catalog number
340.0300.2
Device description
Medical suction unit for suction of secretions, blood, serous fluids, rinsing fluids and temporarily collection of this fluids
Published
2017-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K090445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090445000ATMOS C361/C451 SUCTION PUMPAtmos, Inc.2009-02-27BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250365135992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365135992042503651359924250365135992

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
319591939
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365142297ATMOSHygrotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27

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Primary DI, Brand, Company table
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06978731720013Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
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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
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13