HAMILTON-H900 950004

GUDID 07630002801546

Hamilton Medical AG

Heated respiratory humidifier
Primary Device ID07630002801546
NIH Device Record Key5f7c64c9-b9f0-436d-bea2-265d49cf2187
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAMILTON-H900
Version Model Number950004
Catalog Number950004
Company DUNS481492312
Company NameHamilton Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630002801546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

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 Date2016-09-27

Devices Manufactured by Hamilton Medical AG

07630002800754 - HAMILTON-T12024-08-29
07630002802208 - HAMILTON-G52024-08-29 5900
07630002800730 - HAMILTON-C22024-08-28
07630002802222 - HAMILTON-C32024-08-28
07630002808590 - HAMILTON-C62022-02-03
07630002813426 - HAMILTON-C12022-02-03
07630002813532 - HAMILTON-T12022-02-03
07630002813549 - HAMILTON-T12022-02-03

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