EVA 5 Insufflator

GUDID 05391536920296

Endoscopic Insufflator

PALLIARE LIMITED

Gastrointestinal endoscopic insufflator
Primary Device ID05391536920296
NIH Device Record Key4fa51373-8a7b-49f8-acb2-2437bcfc7bf0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA 5 Insufflator
Version Model NumberEVA5
Company DUNS985710055
Company NamePALLIARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105391536920296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

Devices Manufactured by PALLIARE LIMITED

05391536920142 - EVA152024-07-24 Insufflator Tubeset
05391536920159 - EVA152024-07-24 Insufflator Tubeset
05391536920913 - EVA152024-07-24 LAP300 Laparoscopic Insufflation Tubeset
05391536920944 - EVA152024-07-24 Insufflator Tubeset
05391536920296 - EVA 5 Insufflator2024-05-24Endoscopic Insufflator
05391536920296 - EVA 5 Insufflator2024-05-24 Endoscopic Insufflator
05391536920029 - EVA152023-06-20 Laparoscopic Insufflator and Smoke Evacuation System
05391536920081 - EndoTrap2023-06-20 EndoTrap Endoscopist Protection Device
05391536920012 - EVA152021-05-10 LAP300 Laparoscopic Insufflation Tubeset

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