FDA.report

HUDSON RCI

Primary DI
34026704615668
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049624
Catalog number
7145
Device description
Breathing Circuit, Nonconductive Modified Jackson-Rees (w/ Norman Fresh Gas Elbow and Gas Scavenging Valve)
Published
2019-05-01
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
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704615668PackageGS120In Commercial Distribution
14026704615664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670461566834026704615668
1402670461566414026704615664

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a Dry Cool Place

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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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