DEVICE: LTV (10190752130241)
Device Identifier (DI) Information
LTV
21180-001
In Commercial Distribution
21180-001
VYAIRE MEDICAL, INC.
21180-001
In Commercial Distribution
21180-001
VYAIRE MEDICAL, INC.
Freedom Carrier for LTV & Sprintpack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
38489 | Uninterruptible power supply |
A portable device, commonly known as an uninterruptible power supply (UPS), designed to provide a continuous supply of electrical power for a limited period of time to a connected device or devices during the failure of the mains electricity (AC-power) supply due to an emergency situation, e.g., a blackout, or maintenance/testing. It will contain its own set of batteries that normally maintain their charge from the mains power supply and it is these that provide the power when a failure in the line-power occurs. This device is used locally (at the point of use) and is often reserved to supply vital devices, e.g., ventilators, patient monitoring devices and computer dependent devices.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | Ventilator, continuous, facility use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101643 | 000 |
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
55a4566c-5dfd-40d2-9e8e-6d61a754c3f9
March 02, 2021
1
February 22, 2021
March 02, 2021
1
February 22, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(833)327-3284
customersupport@vyaire.com
customersupport@vyaire.com