SleepmateCannula, Industry Standard CO2 814300-000/25

GUDID 05707480041794

Cannula, Case of 25, Nasal

Ambu A/S

Polysomnograph
Primary Device ID05707480041794
NIH Device Record Key75701348-96cd-4c3e-aca1-9ef1a5b9cb8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateCannula, Industry Standard CO2
Version Model Number814300-000/25
Catalog Number814300-000/25
Company DUNS305682023
Company NameAmbu A/S
Device Count25
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480041794 [Primary]
GS105707480133925 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, breathing frequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-30
Device Publish Date2016-09-21

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