FDA.report

HUDSON RCI

Primary DI
34026704640387
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN913334
Catalog number
1233H
Device description
GAS SAMPLING LINE,10' M/M LUER CONNECTOR
Published
2019-04-23
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
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704640387PackageGS150In Commercial Distribution
04026704581351PreviousGS10
14026704640383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670464038734026704640387
04026704581351040267045813514026704581351
1402670464038314026704640383

GMDN Terms

TermDefinition
Gas-sampling/monitoring respiratory tubing, single-use, non-sterileA non-sterile length of flexible tube(s) primarily intended to be used as an interface between tube/mask breathing circuit connector and a measuring instrument [e.g., a carbon dioxide (C02) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure monitoring and/or gas sampling but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. 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
false
No natural rubber latex
true
Sterilization required before use
false

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