FDA.reportPublic FDA data

Mallinckrodt

Primary DI
30884521133116
Brand
Mallinckrodt
Company
Covidien LP
Model
8888247049
Device description
Nasopharyngeal Airway
Published
2018-09-20
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
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
20884521133119PackageGS110In Commercial Distribution
30884521133116PackageGS110In Commercial Distribution
10884521133112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452113311920884521133119
3088452113311630884521133116
1088452113311210884521133112

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 Gauge30French
Device Size Text, specify0

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
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118618298Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618304Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618311Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618328Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618335Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618342Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
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14026704930606RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930613RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930620RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930637RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28