FDA.reportPublic FDA data

Shiley

Primary DI
50884521133103
Brand
Shiley
Company
Covidien LP
Model
8888247031
Catalog number
8888247031
Device description
Nasopharyngeal Airway
Published
2018-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTQAIRWAY, NASOPHARYNGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K760125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760125000AIRWAY, ARGYLE NASOPHARYNGEALSherwood Medical Industries1976-07-19BTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884521133106PackageGS110In Commercial Distribution
50884521133103PackageGS1100In Commercial Distribution
60884521133100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088452113310640884521133106
5088452113310350884521133103
6088452113310060884521133100

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French
Outer Diameter7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;AVOID DIRECT SUNLIGHT

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704930224RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930231RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704930255RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704930279RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930286RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930514RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930521RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930538RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930545RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930552RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930569RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930576RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930583RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704930606RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704930620RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930637RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
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14026704720078RUSCHTELEFLEX INCORPORATEDBTQ2026-07-27
14026704720085RUSCHTELEFLEX INCORPORATEDBTQ2026-07-27
14026704720092RUSCHTELEFLEX INCORPORATEDBTQ2026-07-27
14026704720115RUSCHTELEFLEX INCORPORATEDBTQ2026-07-27
14026704720122RUSCHTELEFLEX INCORPORATEDBTQ2026-07-27