Neo-natal HMEF

GUDID 35060120951961

GVS FILTER TECHNOLOGY UK LTD

Heat/moisture exchanger, single-use
Primary Device ID35060120951961
NIH Device Record Key0168932d-0285-4692-b6e7-df9554eaab51
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo-natal HMEF
Version Model Number9080/100BAUA001/0001
Company DUNS769934225
Company NameGVS FILTER TECHNOLOGY UK 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115060120951967 [Primary]
GS125060120951964 [Package]
Contains: 15060120951967
Package: Inner box [50 Units]
In Commercial Distribution
GS135060120951961 [Package]
Contains: 25060120951964
Package: Outer box [300 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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