Atos Medical

Primary DI
00817126020009
Brand
Atos Medical
Company
ATOS MEDICAL INC.
Model
9/55
Catalog number
2019-07P1
Device description
Laryngectomy Pulmonary Kit 9/55 W/ Provox 2, Guide Wire, and Provox 2 Plug
Published
2016-09-23
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
00817126020009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817126020009008171260200098171260200090817126020009

GMDN Terms#

Term, Definition table
TermDefinition
Tracheoesophageal speech valve, indwelling, sterileA sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy by a clinician to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The user periodically cleans the device in situ. This is a single-use device.

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
Premarket exempt
true
Kit
true
Combination product
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
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
00817126020078Atos Medical9/552045-412016-09-23