FDA.report

CARDINAL HEALTH

Primary DI
20885380010207
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ADJ26FR
Catalog number
ADJ26FR
Device description
Nasopharyngeal airway - Adjustable Flange, 26Fr/I.D.6.0mm
Published
2016-09-14
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

Related Records

Product Codes

CodeName
BTQAIRWAY, NASOPHARYNGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885380010207PackageGS110In Commercial Distribution
50885380010208PackageGS110In Commercial Distribution
00885380010203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088538001020720885380010207
5088538001020850885380010208
00885380010203008853800102038853800102030885380010203

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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