FDA.reportPublic FDA data

Metaphor Flow Sensor

Primary DI
B23133131
Brand
Metaphor Flow Sensor
Company
TREYMED INC
Model
Infant
Catalog number
3313
Device description
Infant flow sensor. Pack of 10.
Published
2017-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data
BZLComputer, Oxygen-Uptake
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
BZLComputer, Oxygen-UptakeAnesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093080000METAPHOR METABOLIC MONITORTreymed, Inc.2010-01-22BZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B23133131PrimaryHIBCC0
B23133130Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-sampling/monitoring setA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078515394
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B23133121Metaphor Flow SensorAdult/Pediatric33122017-09-27
B23133141Metaphor Flow SensorNeonate33142017-09-27
B23133151Metaphor Flow SensorHigh Flow33152017-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
04036616011983Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-27
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
04036616011839Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011846Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011860Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011877Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011884Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011891Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011907Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011914Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011921Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011938Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011945Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011952Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19