Atos Medical Inc 2010-075

GUDID 00817126021006

Laryngectomy Pulmonary Kit with Standard Provox LaryTube 9/55 and SolaTone Plus Electrolarynx

ATOS MEDICAL INC.

Tracheostoma protective filter
Primary Device ID00817126021006
NIH Device Record Key82c8fdb0-8d23-41b1-9bb3-1084b415ff1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtos Medical Inc
Version Model Number2010-075
Catalog Number2010-075
Company DUNS008224748
Company NameATOS MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com
Phone800-217-0025
Emailinfo.us@atosmedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817126021006 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-21
Device Publish Date2020-02-13

On-Brand Devices [Atos Medical Inc]

00817126021013Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx
00817126021006Laryngectomy Pulmonary Kit with Standard Provox LaryTube 9/55 and SolaTone Plus Electrolarynx
008171260209862010-073 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 10/55 and SolaTone Plusâ„

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