HAMILTON-G5 159001

GUDID 07630002800013

Hamilton Medical AG

Neonatal/adult intensive-care ventilator
Primary Device ID07630002800013
NIH Device Record Key5924a3aa-ab69-4c4e-815e-c3d1c7931282
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAMILTON-G5
Version Model Number159001
Catalog Number159001
Company DUNS481492312
Company NameHamilton Medical AG
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 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
GS107630002800013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-13
Device Publish Date2015-10-21

Devices Manufactured by Hamilton Medical AG

07630002808590 - HAMILTON-C62022-02-03
07630002813426 - HAMILTON-C12022-02-03
07630002813532 - HAMILTON-T12022-02-03
07630002813549 - HAMILTON-T12022-02-03
07630002813556 - HAMILTON-MR12022-02-03
07630002800013 - HAMILTON-G52020-01-13
07630002800013 - HAMILTON-G52020-01-13
07630002800846 - HAMILTON-BC80102019-11-27 HAMILTON-BC8010, breathing circuit set, dual limb, heated, with water chamber
07630002801416 - HAMILTON-BC40102019-11-27 HAMILTON-BC4010, breathing circuit set, single limb, heated, with water chamber

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