ECO Range - Maxi Series

GUDID 35019315083222

GVS Technology (Suzhou) Co., Ltd.

Heat/moisture exchanger, single-use
Primary Device ID35019315083222
NIH Device Record Key24669f40-7865-40f3-8208-697f04e0c197
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Range - Maxi Series
Version Model Number62.002.0135.4333/751BRSA
Company DUNS420798347
Company NameGVS Technology (Suzhou) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS115019315083228 [Primary]
GS135019315083222 [Package]
Contains: 15019315083228
Package: Carton [50 Units]
In Commercial Distribution

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

On-Brand Devices [ECO Range - Maxi Series]

3501931508329162.002.0079.4244/711CRSA
3501931508322262.002.0135.4333/751BRSA
3501931508321562.002.0070.4333/710CRSA
3501931508298062.002.0131.4333/750BRSA

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