FDA.reportPublic FDA data

Teledyne Analytical Instruments

Primary DI
00852470008105
Brand
Teledyne Analytical Instruments
Company
Teledyne Analytical Instrs
Model
UFO-130
Device description
Oxygen Sensor
Published
2019-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001095000OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130Teledyne Analytical Instruments2000-06-30CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852470008105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852470008105008524700081058524700081050852470008105

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen sensorA device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078344505
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852470008150Teledyne Analytical InstrumentsR232022-04-06
00852470008174Teledyne Analytical InstrumentsC1R2022-04-06
00852470008013Teledyne Analytical InstrumentsAX3002019-03-05
00852470008020Teledyne Analytical InstrumentsMX3002019-03-05
00852470008044Teledyne Analytical InstrumentsR152019-03-05
00852470008143TeledyneC12020-03-05
00852470008129TeledyneR29MED2019-08-29
00852470008136TeledyneR29IMED2019-08-29
00852470008006Teledyne Analytical InstrumentsR22MED2019-03-05
00852470008037Teledyne Analytical InstrumentsR17MED2019-03-05
00852470008051Teledyne Analytical InstrumentsR24MED2019-03-05
00852470008068Teledyne Analytical InstrumentsR26MED2019-03-05
00852470008075Teledyne Analytical InstrumentsR36MED2019-03-05
00852470008082Teledyne Analytical InstrumentsT12019-03-05
00852470008099Teledyne Analytical InstrumentsT72019-03-05
00852470008112Teledyne Analytical InstrumentsUFO-130-22019-03-05

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Primary DI, Brand, Company table
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