FDA.report

McKesson

Primary DI
00612479208698
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-3318E
Device description
Nasal Cannula ADULT, CONTOURED TIP, UNIVERSAL CONNECTOR 7’ (2.1 m) CRUSH RESISTANT TUBING | SINGLE PATIENT USE
Published
2019-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479208698PackageGS150In Commercial Distribution
00612479208681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479208698006124792086986124792086980612479208698
00612479208681006124792086816124792086810612479208681

GMDN Terms

TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. 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
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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20612479283415McKessonM-J546G2026-05-26

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