FDA.report

McKesson

Primary DI
00612479248304
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
159-75-30
Device description
Nasopharyngeal Airway 30Fr | ROBERTAZZI (10/bx)
Published
2019-09-24
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

Related Records

Product Codes

CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications

CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479248304PackageGS110In Commercial Distribution
00612479248298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479248304006124792483046124792483040612479248304
00612479248298006124792482986124792482980612479248298

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
023904428
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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