DEVICE: Medisorb™ (70190752178917)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Medisorb™
1407-3201-000
In Commercial Distribution
1407-3201-000
AirLife Finland Oy
1407-3201-000
In Commercial Distribution
1407-3201-000
AirLife Finland Oy
Dust Filter for Reusable Multi-Absorber
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 42414 | Carbon dioxide absorber, single-use |
A non-sterile, prefilled, sealed container (i.e., a canister with connectors) that constitutes a complete anaesthesia absorber, which is intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled by the manufacturer with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime) to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CBL | Absorbent, Carbon-Dioxide |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -4 and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify: Keep Away from Sunlight |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c38dbed1-d1fa-4682-972a-f73ee74bf58b
October 02, 2025
5
September 03, 2021
October 02, 2025
5
September 03, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
10190752178915
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-833-327-3284
customersupport@vyaire.com
customersupport@vyaire.com