Atos Medical

Primary DI
00817126020542
Brand
Atos Medical
Company
ATOS MEDICAL INC.
Model
12/55
Catalog number
2010-053
Device description
Custom Laryngectomy Pulmonary Kit 12/55 With Provox® Standard LaryTube™ & TruTone™ Electrolarynx
Published
2017-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817126020542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817126020542008171260205428171260205420817126020542

GMDN Terms#

Term, Definition table
TermDefinition
Transcervical artificial larynxA battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Do not store in direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-217-0025info.us@atosmedical.com

Regulatory Flags#

DUNS number
008224748
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817126020894Atos Medical2010-0642010-0642019-02-15
00817126020900Atos Medical2010-0652010-0652019-02-15
00817126020917Atos Medical2010-0662010-0662019-02-15
00817126020924Atos Medical2010-0672010-0672019-02-28
00817126020962Atos Medical2010-0712010-0712019-08-07
00817126020986Atos Medical Inc2010-0732010-0732019-12-19
00817126020993Atos Medical2010-0742010-0742019-12-20
00817126021006Atos Medical Inc2010-0752010-0752020-02-13
00817126021013Atos Medical Inc2010-0762010-0762020-02-13
00817126020979Atos Medical Inc.2010-0722010-0722019-09-25
00817126020955Atos Medical2010-0702010-0702019-06-06
00817126020948Atos Medical2010-0692010-0692019-04-25
00817126020931Atos Medical2010-0682010-0682019-04-16
00817126020009Atos Medical9/552019-07P12016-09-23
00817126020016Atos Medical9/552041-412016-09-23
00817126020023Atos Medical9/362018-06P12016-09-23
00817126020030Atos Medical9/552045-072016-09-23
00817126020047Atos Medical9/362019-06P12016-09-23
00817126020054Atos Medical9/552023-072016-09-23
00817126020061Atos Medical10/552023-112016-09-23