FDA.report

McKesson

Primary DI
00612479256095
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
82114
Device description
Airway Kit Berman Color-Coded
Published
2020-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479256095PackageGS112In Commercial Distribution
00612479256088PrimaryGS10
00612479256071Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479256095006124792560956124792560950612479256095
00612479256088006124792560886124792560880612479256088
00612479256071006124792560716124792560710612479256071

GMDN Terms

TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
6
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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