FDA.reportPublic FDA data

Adult Bacterial/Viral Filter with C02 Port

Primary DI
00858409005368
Brand
Adult Bacterial/Viral Filter with C02 Port
Company
Medicomp
Model
MC-555X
Catalog number
MC-555X
Published
2017-09-11
Public version status
Update
Distribution status
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
10858409005365PackageGS150In Commercial Distribution
00858409005368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085840900536510858409005365
00858409005368008584090053688584090053680858409005368

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific 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 (excludes 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.

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
00858409005023Nebulizer Bacteria FilterMC-350MC-3502017-09-11
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
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

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Primary DI, Brand, Company table
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