SleepmateVelstretch Band Large, Lt. Grey 813003-100

GUDID 05707480041442

ref. 1340

Ambu A/S

Polysomnograph
Primary Device ID05707480041442
NIH Device Record Keye0758e98-9773-493c-a7ba-afb9fec67af1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepmateVelstretch Band Large, Lt. Grey
Version Model Number813003-100
Catalog Number813003-100
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
GS105707480041442 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

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