FDA.report

HUDSON RCI

Primary DI
34026704627739
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049284
Catalog number
031-28
Device description
NEBULIZER ADAPTOR 028,STERILE,SHELFPAK
Published
2018-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704627739PackageGS150In Commercial Distribution
04026704597116PreviousGS10
14026704627735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670462773934026704627739
04026704597116040267045971164026704597116
1402670462773514026704627735

GMDN Terms

TermDefinition
Inhalation-therapy adaptor, reusableA small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system) when the connection is not compatible (e.g., when the humidifier and the sterile water pack are of different manufacture). This is a reusable 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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