Inlet Filter - Regular

Primary DI
07290017096964
Brand
Inlet Filter - Regular
Company
INOVYTEC MEDICAL SOLUTIONS LTD
Model
VWSP-460
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202970000Ventway SparrowInovytech Medical Solutions , Ltd.2021-01-29CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017096961PackageGS15In Commercial Distribution
07290017096964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001709696117290017096961
07290017096964072900170969647290017096964

GMDN Terms#

Term, Definition table
TermDefinition
Gas sampling line filter, single-useA screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+97299656485info@inovytec.com

Regulatory Flags#

DUNS number
649213584
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017096766Patient Circuit - Adult, 1.8m, 1 pcs, one wayVWSP-450F2023-01-11
07290017096773Patient Circuit - Pediatric, 1.8m, 1 pcs, one wayVWSP-550F2023-01-11
17290017096763Patient Circuit - Adult, 1.8m, 1 pcs, one wayVWSP-450F2023-01-11
17290017096770Patient Circuit - Pediatric, 1.8m, 1 pcs, one wayVWSP-550F2023-01-11
07290017096889Patient Circuit - Adult, 2.4m, 1 pcsVWSP-3702023-01-11
07290017096902Patient Circuit - Pediatric, 2.4m, 1 pcsVWSP-3902023-01-11
07290017096728Ventway Sparrow MRIVWSP-100MR2023-01-11
07290017096735Ventway Sparrow Robust Ventilator MRI CompatibleVWSP-900MR2023-01-11
07290017096742Ventway Sparrow MRI PackagedVWSP-1000MR2023-01-11
07290017096759Ventway Sparrow MRI Robust PackagedVWSP-9000MR2023-01-11
07290017096803Ventway SparrowVWSP-1002023-01-11
07290017096810Ventway Sparrow PackagedVWSP-10002023-01-11
07290017096834Ventway Sparrow RobustVWSP-9002023-01-11
07290017096841Ventway Sparrow Robust PackagedVWSP-90002023-01-11
07290017096926Oxygen MixerVWSP-5802023-01-11
07290017096933Oxygen Enrichment KitVWSP-3042023-01-11

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