Shiley

Primary DI
50884522005379
Brand
Shiley
Company
Covidien LP
Model
SSVO
Catalog number
SSVO
Device description
Speaking Valve,O2 Port
Published
2015-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945407000SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORTMallinckrodt Medical Tpi, Inc.1995-02-27BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884522005379PackageGS1108In Commercial Distribution
40884522005372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088452200537950884522005379
4088452200537240884522005372

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube speech valveA device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
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10884521543881SigniaSIGMRET2017-07-24
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10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

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