Patient Circuit - Adult, 1.8m, 1 pcs, one way

Primary DI
17290017096763
Brand
Patient Circuit - Adult, 1.8m, 1 pcs, one way
Company
INOVYTEC MEDICAL SOLUTIONS LTD
Model
VWSP-450F
Published
2023-01-11
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

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
17290017096763PackageGS110In Commercial Distribution
07290017096766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001709676317290017096763
07290017096766072900170967667290017096766

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, single-useA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and/or with other separate gas delivery devices (e.g., inhalational analgesia gas administration set, respiratory mask); connectors may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
649213584
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
false
Sterilization required before use
false

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
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
07290017096964Inlet Filter - RegularVWSP-4602023-01-11

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