SleepmateAC Body Position Sensor Kit 815600-100

GUDID 05707480042272

Ref. 1520

Ambu A/S

Polysomnograph
Primary Device ID05707480042272
NIH Device Record Key3ebaf73f-65d0-4053-9d1a-a68d673b6b76
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateAC Body Position Sensor Kit
Version Model Number815600-100
Catalog Number815600-100
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
GS105707480042272 [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

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