FDA.reportPublic FDA data

Heat and Moisture Exchanger Filter with Gas Sampling Port

Primary DI
16959180703861
Brand
Heat and Moisture Exchanger Filter with Gas Sampling Port
Company
VR Medical Technology Co., Ltd.
Model
VR008
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
16959180703861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1695918070386116959180703861

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
16959180703878Breathing Filter VR0102016-09-02
16959180703885HEPA Breathing Filter VR0122016-09-20
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

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Primary DI, Brand, Company table
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B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
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00848530109257Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
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08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
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008485301044366IN HEPA Capsule with Removable StickerSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104863Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104672Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-04-21