DEVICE: Heated Circuit (00709078001086)

Device Identifier (DI) Information

Heated Circuit
9313
In Commercial Distribution

WESTMED, INC.
00709078001086
GS1

1
092673953 *Terms of Use
72` Ped.Htd Wick,BV,1LF,3pk ECG,GSL,14FR.O2 cath.,24` tube
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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No
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GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37704 Anaesthesia breathing circuit, single-use
An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.
Active false
60965 Respiratory gas heating wire, infant
A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an infant/neonate. It typically consists of a compact heating unit which and a length of heated wire which is integrated within the lumen of a neonatal/paediatric breathing circuit tube. This is a reusable device.
Active false
46816 Heat/moisture exchanger/microbial medical gas filter
A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAH Filter, Bacterial, Breathing-Circuit
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3bba506c-dbb6-42f6-aaa6-c74a063f9d0e
October 24, 2022
5
November 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10709078001083 18 00709078001086 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
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Customer Contact

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No Customer Contact currently defined
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