FDA.reportPublic FDA data

HEPA Breathing Filter

Primary DI
16959180703885
Brand
HEPA Breathing Filter
Company
VR Medical Technology Co., Ltd.
Model
VR012
Published
2016-09-20
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
K132709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132709000VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERVr Medical2014-07-30CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959180703885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1695918070388516959180703885

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420798349
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16959180715697VR Medical Technology Co., Ltd.Closed suction System VR0416082024-08-19
16959180720479VR Medical Technology Co., Ltd.Closed suction System VR0416052024-08-19
16959180731987VR Medical Technology Co., Ltd.Closed suction System VR0416062024-08-19
16959180753194VR Medical Technology Co., Ltd.Closed suction System VR0416072024-08-19
16959180705513Heat Moisture Exchanger and FilterVR0232019-08-20
16959180703830Heat and Moisture Exchanger Filter with Gas Sampling PortVR0032016-09-20
16959180703847Heat and Moisture Exchanger Filter with Gas Sampling Port VR0052016-09-20
16959180703854Heat and Moisture Exchanger Filter VR10002016-09-20
16959180703861Heat and Moisture Exchanger Filter with Gas Sampling Port VR0082016-09-20
16959180703878Breathing Filter VR0102016-09-02
16959180703892Heat and Moisture Exchanger Filter with Flexible Tube VR0272016-09-20
16959180704677Heat and Moisture Exchanger Filter VR0892018-02-07
16959180703908Adult Flex TubingVR0172018-02-07
16959180703915Pediatric Flex Tubing VR0182018-02-07
16959180703731Closed Suction SystemVR04114US2020-05-06
16959180704219Closed Suction SystemVR04210US2020-05-06
16959180704318Closed Suction SystemVR04810US2020-05-06
16959180704332Closed Suction SystemVR04814US2020-05-06
16959180704417Closed Suction SystemVR041110US2020-05-06
16959180704431Closed Suction SystemVR041114US2020-05-06

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
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
10190752135987Vital Signs™AirLife Finland OyCAH2021-03-05
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10190752136632Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136793Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
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