FDA.report

HUDSON RCI

Primary DI
24026704659948
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN913791
Catalog number
780-08KIT
Device description
NEONATAL BREATHING CIRCUIT WITH COLUMN
Published
2019-08-05
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
true

Related Records

Contact Domains

Product Codes

CodeName
OGGHumidifier nebulizer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704659948PackageGS120In Commercial Distribution
04026704598007PreviousGS10
14026704659941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670465994824026704659948
04026704598007040267045980074026704598007
1402670465994114026704659941

GMDN Terms

TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. 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
true
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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