Oxygen Enrichment Kit

Primary DI
07290017096933
Brand
Oxygen Enrichment Kit
Company
INOVYTEC MEDICAL SOLUTIONS LTD
Model
VWSP-304
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
07290017096933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017096933072900170969337290017096933

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Contacts#

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

Regulatory Flags#

DUNS number
649213584
Device count
1
Lot or batch
true
Serial number
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
07290017096964Inlet Filter - RegularVWSP-4602023-01-11

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Primary DI, Brand, Company table
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