SleepmateCannuTherm, - Alice 5 814310-121

GUDID 05707480042043

Ref. 1464

Ambu A/S

Polysomnograph
Primary Device ID05707480042043
NIH Device Record Keyd1458655-4816-4a3a-9a70-be5bd9340120
Commercial Distribution Discontinuation2017-10-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSleepmateCannuTherm, - Alice 5
Version Model Number814310-121
Catalog Number814310-121
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
GS105707480042043 [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

Devices Manufactured by Ambu A/S

05707480159154 - Ambu® SureSight® Blade2025-05-16 Video Laryngoscope Blade
05707480159109 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159123 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159192 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159222 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480157167 - Ambu® aScope™ Duodeno 22025-04-07 Duodenoscope
05707480159246 - Ambu® SureSight® Blade2024-12-23 Video Laryngoscope Blade
05707480159277 - Ambu® SureSight® Blade2024-12-23 Video Laryngoscope Blade

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.