FDA.report

Ventlab

Primary DI
20889483078720
Brand
Ventlab
Company
VENTLAB, LLC
Model
BF102
Device description
19mm Disposable Bacterial/Viral Filter
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications

CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20889483078720PackageGS150In Commercial Distribution
10889483078723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088948307872020889483078720
1088948307872310889483078723

GMDN Terms

TermDefinition
Microbial medical gas filter, non-sterile, single-useA non-sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter19Millimeter
Lumen/Inner Diameter22Millimeter
Outer Diameter30Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00General Warehouse. Do not get wet.

Sterilization Methods

Method

Contacts

PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags

DUNS number
038305402
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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30889483631533AirFlow™AF5102MC-PAF5102MC-P2025-01-31
10889483555675VentlabAF2142MB-M5EAF2142MB-M5E2024-03-12
10889483555682VentlabAF5000MB-EAF5000MB-E2024-03-12
10889483555699VentlabAF5040MB-EAF5040MB-E2024-03-12
10889483555705VentlabAF5040MBP-EAF5040MBP-E2024-03-12
10889483555712VentlabAF5140MB-EAF5140MB-E2024-03-12
10889483555729VentlabAF5140MBP-EAF5140MBP-E2024-03-12
10889483555736VentlabAF5142MBP-EAF5142MBP-E2024-03-12
10889483555743VentlabAF2000MB-EAF2000MB-E2024-03-12
10889483555750VentlabAF2040MB-EAF2040MB-E2024-03-12
10889483555767VentlabAF2040MBP-EAF2040MBP-E2024-03-12
10889483555774VentlabAF2140MB-EAF2140MB-E2024-03-12
10889483555781VentlabAF2140MBP-EAF2140MBP-E2024-03-12
10889483555798VentlabAF2142MBP-EAF2142MBP-E2024-03-12
10889483555804VentlabAF2144MB-EAF2144MB-E2024-03-12
10889483555811VentlabAF5140MB-ZAF5140MB-Z2024-03-12
10889483555828VentlabAF5140MBP-ZAF5140MBP-Z2024-03-12
10889483555835VentlabAF5040MBP-ZAF5040MBP-Z2024-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
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