HAMILTON-BC8010 260185

GUDID 07630002800846

HAMILTON-BC8010, breathing circuit set, dual limb, heated, with water chamber

Hamilton Medical AG

Ventilator breathing circuit, single-use
Primary Device ID07630002800846
NIH Device Record Key4cfd8067-72a4-444f-b9ce-de4620bf38e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAMILTON-BC8010
Version Model Number260185
Catalog Number260185
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com
Phone(775) 858-3200
Emailinfo@hamiltonmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107630002800846 [Primary]
GS117630002800843 [Package]
Package: [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-10-04

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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