Patient Circuit - Pediatric, 2.4m, 1 pcs

GUDID 07290017096902

INOVYTEC MEDICAL SOLUTIONS LTD

Inspiratory/expiratory limb respiratory tubing, single-use
Primary Device ID07290017096902
NIH Device Record Key66c2f44a-d0e3-446a-b722-2149e196f51c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Circuit - Pediatric, 2.4m, 1 pcs
Version Model NumberVWSP-390
Company DUNS649213584
Company NameINOVYTEC MEDICAL SOLUTIONS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com
Phone+97299656485
Emailinfo@inovytec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017096902 [Primary]
GS117290017096909 [Package]
Package: [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-06
Device Publish Date2023-01-11

Devices Manufactured by INOVYTEC MEDICAL SOLUTIONS LTD

17290017096763 - Patient Circuit - Adult, 1.8m, 1 pcs, one way2023-07-06
17290017096770 - Patient Circuit - Pediatric, 1.8m, 1 pcs, one way2023-07-06
07290017096889 - Patient Circuit - Adult, 2.4m, 1 pcs2023-07-06
07290017096902 - Patient Circuit - Pediatric, 2.4m, 1 pcs2023-07-06
07290017096902 - Patient Circuit - Pediatric, 2.4m, 1 pcs2023-07-06

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