FDA.reportPublic FDA data

Nebulizer Bacteria Filter

Primary DI
00858409005023
Brand
Nebulizer Bacteria Filter
Company
Medicomp
Model
MC-350
Catalog number
MC-350
Published
2017-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851070000RESP-BAC BACTERIA FILTERMedicomp, Inc.1985-06-14CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858409005023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858409005023008584090050238584090050230858409005023

GMDN Terms#

Term, Definition table
TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with standardized connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154454730
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858409005009Adult Bacterial/Viral FilterMC-500MC-5002016-09-26
00858409005269Small/Medium CPAP Cap OnlyMC-1111MC-11112017-09-11
00858409005276Large CPAP Cap OnlyMC-1212MC-12122017-09-11
00858409005436Small/Medium CPAP Cap Only MC-1111SSMC-1111SS2017-09-11
00858409005443Large CPAP Cap OnlyMC-1212SSMC-1212SS2017-09-11
00858409005016Infant Bacterial/Viral FilterMC-125MC-1252017-09-11
00858409005399Metered Dose ElbowMC-1423MC-14232017-09-11
00858409005405Metered Dose Straight SwivelMC-1523MC-15232017-09-11
00858409005030Spirometer Bacterial/Viral FilterMC-850MC-8502017-09-11
00858409005290Bronchoscopy Suction Swivel AdapterMC-3125MC-31252017-09-11
00858409005337Dual Swivel ElbowMC-4450MC-44502017-09-15
00858409005344Dual Swivel Elbow with Suction PortMC-4475MC-44752017-09-15
00858409005351Single Straight Swivel ConnectorMC-4490MC-44902017-09-15
00858409005368Adult Bacterial/Viral Filter with C02 PortMC-555XMC-555X2017-09-11
00858409005450"Dual Swivel Elbow, 6"" Expandable Tubing"MC-5450MC-54502017-09-15
00858409005467"Dual Swivel Elbow, 6"" Expandable Tubing with 22F Connector"MC-5460MC-54602017-09-15
00858409005474"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing"MC-5475MC-54752017-09-15
00858409005481"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing with 22F Connector"MC-5480MC-54802017-09-15
00858409005498"Single Straight Swivel Connector, 6"" Expandable Tubing"MC-5490MC-54902017-09-15
00858409005504"Single Straight Swivel Connector, 6"" Expandable Tubing with 22F Connector"MC-5495MC-54952017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
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10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140080Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140097AirLife™AirLife Finland OyCAH2021-03-05
10190752136724Vital SignsAirLife Finland OyCAH2021-03-01
10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04