FDA.report

HUDSON RCI

Primary DI
04026704558896
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049729
Catalog number
1853
Device description
Pediatric Softech Plus Nasal Cannula W/14 ft(4.3m) Green 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
04026704558896PackageGS150In Commercial Distribution
24026704558890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704558896040267045588964026704558896
2402670455889024026704558890

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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