SAVe II+

GUDID 20851629008076

SAVe II+ Kit, A&C plugs

Automedx, LLC

Transport electric ventilator
Primary Device ID20851629008076
NIH Device Record Key431bbb0c-6ff7-439f-b9b0-4008b15bb7a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAVe II+
Version Model Number70110H-EU
Company DUNS606696123
Company NameAutomedx, LLC
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

Customer Support Contacts

Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com
Phone18554286074
Emailinfo@safeguardmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120851629008076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-15
Device Publish Date2024-01-06

On-Brand Devices [SAVe II+]

90851629008075SAVe II+ US Kit with Mask & Headstrap
20851629008076SAVe II+ Kit, A&C plugs
10851629008079SAVe II+ Kit, US Plug
00851629008072SAVe II+ Ventilator

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