ECO Maxi HME

GUDID 15060120952636

GVS Technology (Suzhou) Co., Ltd.

Heat/moisture exchanger, single-use
Primary Device ID15060120952636
NIH Device Record Key3c522025-a86d-425f-ab40-6cc55622b3f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Maxi HME
Version Model Number62.002.0075.4333/711RRSA
Company DUNS420798347
Company NameGVS Technology (Suzhou) Co., Ltd.
Device Count50
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
GS115060120952636 [Primary]
GS115060120952639 [Unit of Use]

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

On-Brand Devices [ECO Maxi HME]

1506012095268162.002.0101.4333/751RRSA
1506012095263662.002.0075.4333/711RRSA

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