SleepmatePiezo Limb Sensor - Replacement 817230-100

GUDID 05707480042890

Ref. 1770

Ambu A/S

Polysomnograph
Primary Device ID05707480042890
NIH Device Record Key794b2747-7ced-4a67-ab5c-14f37a8d8794
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmatePiezo Limb Sensor - Replacement
Version Model Number817230-100
Catalog Number817230-100
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
GS105707480042890 [Primary]
GS105707480096800 [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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