SleepmateCannuTherm Thermocouple - 90 cm 814850-100

GUDID 05707480106547

CannuTherm Thermocouple - 90 cm wire

Ambu A/S

Polysomnograph
Primary Device ID05707480106547
NIH Device Record Keyee649934-1dc2-4b36-ad36-60794abc3ffb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateCannuTherm Thermocouple - 90 cm
Version Model Number814850-100
Catalog Number814850-100
Company DUNS305682023
Company NameAmbu A/S
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 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 Identifiers

Device Issuing AgencyDevice ID
GS105707480106547 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

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