FDA.report

RUSCH

Primary DI
34026704543954
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN044985
Catalog number
568000
Device description
RUSCH® Fox Post-Nasal Tube With 10cc Syringe, Red Rubber, Soft latex balloon
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMXBALLOON, EPISTAXIS

Product Code Classifications

CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704543954Direct MarkingGS10
24026704543957PackageGS112Not in Commercial Distribution
04026704543953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670454395434026704543954
2402670454395724026704543957
04026704543953040267045439534026704543953

GMDN Terms

TermDefinition
Epistaxsis balloonA device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. 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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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