SleepmateUARS Starter Kit (Cable interface & 5 Sen 816400-100

GUDID 05707480041893

Ref. 1600 Cable, Interface & 5 Sensors

Ambu A/S

Polysomnograph
Primary Device ID05707480041893
NIH Device Record Keye3e88f41-f4ef-4777-abe7-53c758f77561
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateUARS Starter Kit (Cable interface & 5 Sen
Version Model Number816400-100
Catalog Number816400-100
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
GS105707480041893 [Primary]
GS105707480101351 [Direct Marking]

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 Number4
Public Version Date2018-10-29
Device Publish Date2016-09-21

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