FDA.reportPublic FDA data

HME/BFE/VFE/ without Gas Sampling Port; Straight; 15F/22M-22F

Primary DI
10858409005167
Brand
HME/BFE/VFE/ without Gas Sampling Port; Straight; 15F/22M-22F
Company
Medicomp
Model
MC-775
Catalog number
MC-775
Published
2017-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858409005167PackageGS150In Commercial Distribution
00858409005160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085840900516710858409005167
00858409005160008584090051608584090051600858409005160

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial filter, non-sterileA non-sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154454730
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
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