ECO Range - Mini Series

GUDID 35019315082997

GVS Technology (Suzhou) Co., Ltd.

Heat/moisture exchanger, single-use
Primary Device ID35019315082997
NIH Device Record Keyb00a20c4-d725-4341-8fcd-fc5dc70210e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Range - Mini Series
Version Model Number62.002.0087.9067/710CRSA
Company DUNS420798347
Company NameGVS Technology (Suzhou) Co., 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
GS115019315082993 [Primary]
GS135019315082997 [Package]
Contains: 15019315082993
Package: Carton [50 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

On-Brand Devices [ECO Range - Mini Series]

3501931508301762.002.0089.9067/750BRSB
3501931508299762.002.0087.9067/710CRSA

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