SleepmateBody Position Sensor 69391

GUDID 05707480043477

CareFusion Body Position Sensor

Ambu A/S

Polysomnograph
Primary Device ID05707480043477
NIH Device Record Keyb35a7458-18ba-49da-bc21-561c60f8ff7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateBody Position Sensor
Version Model Number69391
Catalog Number69391
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
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480043477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXJSystem, optical position/movement recording

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-03

Devices Manufactured by Ambu A/S

05707480164486 - Ambu® aScope™ 5 Cysto HD2024-11-14 Flexible Cystoscope, Reverse Deflection
05707480164516 - Ambu® aScope™ 5 Cysto HD2024-11-14 Flexible Cystoscope, Standard Deflection
05707480157136 - Ambu® aScope™ Duodeno 22024-07-29 Duodenoscope
05707480006540 - Immobilization Kit, with2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
05707480006557 - Immobilization Kit, with2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
05707480037308 - Immobilization Kit, with2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
05707480038626 - Immobilization Kit, with2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
05707480006601 - Silicone Face Mask2024-07-16 Reusable face mask

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.