ECO Micro HMEF

GUDID 15060120952643

GVS Technology (Suzhou) Co., Ltd.

Heat/moisture exchanger, single-use
Primary Device ID15060120952643
NIH Device Record Keyda3c22c2-c50e-4b3f-b8eb-b306a87a6a83
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Micro HMEF
Version Model Number62.002.0080.9080/710RRSA
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
GS115060120952643 [Primary]
GS115060120952646 [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

Devices Manufactured by GVS Technology (Suzhou) Co., Ltd.

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