FDA.reportPublic FDA data

Shiley

Primary DI
20884521815831
Brand
Shiley
Company
Covidien LP
Model
8888247015
Device description
Nasopharyngeal Airway
Published
2021-08-15
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
20884521815831PackageGS110In Commercial Distribution
30884521815838PackageGS110In Commercial Distribution
10884521815834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452181583120884521815831
3088452181583830884521815838
1088452181583410884521815834

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 Gauge24French
Outer Diameter6Millimeter

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
false
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
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479273276McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273290McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273313McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273337McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273351McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273375McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273399McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273412McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273436McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00810094576639CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576646CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576653CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576660CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576677CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576684CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576691CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576707CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576714CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576721CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576738CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576745CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576752CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810003751034KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751041KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751058KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751065KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751072KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751089KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751096KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751102KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14