Snoring Sensor 78 inSleepmate 1420605

GUDID 05707480043224

Snoring Sensor 78"/200 cm

Ambu A/S

Polysomnograph
Primary Device ID05707480043224
NIH Device Record Keyf84d1ccc-3f8f-4a25-a19d-46d3194b2336
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnoring Sensor 78 inSleepmate
Version Model Number1420605
Catalog Number1420605
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480043224 [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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