DEVICE: AirLife (10885403039980)
Device Identifier (DI) Information
AirLife
RT510-853
Not in Commercial Distribution
RT510-853
Carefusion Corporation
RT510-853
Not in Commercial Distribution
RT510-853
Carefusion Corporation
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
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No |
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? |
---|---|---|---|---|
61833 | Inspiratory/expiratory limb respiratory tubing, reusable |
A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.
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Active | false |
37706 | Ventilator breathing circuit, single-use |
An 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 artificial airway/respiratory mask (not included). 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 a carbon dioxide cuvette and/or 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.
|
Active | false |
35122 | Metered dose inhaler |
A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZE | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cd02fafe-c8c5-47bd-8644-4487d7043d8f
May 22, 2024
6
September 01, 2016
May 22, 2024
6
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50885403039988 | 20 | 10885403039980 | 2022-03-31 | Not in Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)323-9088
gmb-MedSpec-CustService@carefusion.com
gmb-MedSpec-CustService@carefusion.com