DEVICE: Ultramax (00087770020929)

Device Identifier (DI) Information

Ultramax
R221P11
In Commercial Distribution

MAXTEC, LLC
00087770020929
GS1

1
169911828 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Respiratory oxygen monitor, line-powered A mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes.
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FDA Product Code

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Product Code Product Code Name
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112402 000
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Sterilization

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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

d215d2ef-94dc-4616-ab8a-12496ee276bd
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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
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No
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Customer Contact

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No Customer Contact currently defined
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