DEVICE: Metaphor Flow Sensor (B23133131)

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Device Record History
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Device Identifier (DI) Information
Metaphor Flow Sensor
Infant
In Commercial Distribution
3313
TREYMED INC
B23133131
HIBCC

10
078515394 *Terms of Use
Infant flow sensor. Pack of 10.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
61834 Breathing circuit gas-sampling/monitoring set
A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZL Computer, Oxygen-Uptake
BZC Calculator, Pulmonary Function Data
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
DQA Oximeter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K093080 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
f9da1215-b47d-4532-84fc-ae16527884c5
July 06, 2018
3
September 27, 2017
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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: B23133130 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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