FDA.report

HUDSON RCI

Primary DI
34026704625391
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049745
Catalog number
1826
Device description
Pediatric Softech Nasal Cannula W/7ft(2.1m) Star Lumen Tubing W/ Universal Oxygen Connector
Published
2018-11-07
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
34026704625391PackageGS150In Commercial Distribution
14026704625397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670462539134026704625391
1402670462539714026704625397

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
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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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