FDA.report

DUAL LUMEN, ADULT, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.5M

Primary DI
05030267117291
Brand
DUAL LUMEN, ADULT, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.5M
Company
INTERSURGICAL INCORPORATED
Model
1165013
Device description
DUAL LUMEN, ADULT, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.5M
Published
2021-10-22
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

Contact Domains

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267117291PackageGS150In Commercial Distribution
05030267112319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267117291050302671172915030267117291
05030267112319050302671123195030267112319

GMDN Terms

TermDefinition
Basic 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 administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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