Sleepmate / SparepartBody Position Band 815000-000

GUDID 05707480042548

Body Position Band

Ambu A/S

Polysomnograph
Primary Device ID05707480042548
NIH Device Record Key112611b8-38bb-4fc7-9b02-a8b0628bcb7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmate / SparepartBody Position Band
Version Model Number815000-000
Catalog Number815000-000
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480042548 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-04
Device Publish Date2019-01-10

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