FDA.reportPublic FDA data

Analytical Industries Inc.

Primary DI
00897772002338
Brand
Analytical Industries Inc.
Company
ANALYTICAL INDUSTRIES INC.
Model
PSR-11-60-23A
Device description
Oxygen Sensor
Published
2017-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K952736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952736000PERCENT OXYGEN SENSORAnalytical Industries, Inc.1995-10-18CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00897772002338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897772002338008977720023388977720023380897772002338

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.

Regulatory Flags#

DUNS number
931420624
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897772002017Analytical Industries Inc.AII-2000M2017-01-18
00897772002031Analytical Industries Inc.AII-11-602017-01-17
00897772002048Analytical Industries Inc.PSR-11-332017-01-17
00897772002055Analytical Industries Inc.PSR-11-33-12017-01-13
00897772002062Analytical Industries Inc.PSR-11-33-22017-01-13
00897772002079Analytical Industries Inc.PSR-11-552017-01-16
00897772002086Analytical Industries Inc.PSR-11-582017-01-24
00897772002093Analytical Industries Inc.PSR-11-58-HC2017-01-16
00897772002109Analytical Industries Inc.PSR-11-917-J2017-01-10
00897772002116Analytical Industries Inc.PSR-11-917-J12017-01-16
00897772002123Analytical Industries Inc.PSR-11-917-J22017-01-16
00897772002130Analytical Industries Inc.PSR-11-917-J32017-01-13
00897772002154Analytical Industries Inc.PSR-11-75-KE12017-01-17
00897772002161Analytical Industries Inc.PSR-11-75-KE22017-01-16
00897772002178Analytical Industries Inc.PSR-11-75-KE42017-01-10
00897772002185Analytical Industries Inc.PSR-11-75-KE62017-01-17
00897772002192Analytical Industries Inc.PSR-11-75-KE72017-01-10
00897772002208Analytical Industries Inc.PSR-11-75-KE82017-01-17
00897772002215Analytical Industries Inc.PSR-11-917-M2017-01-10
00897772002222Analytical Industries Inc.PSR-11-917-M12017-01-13

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10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
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00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
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00840682104302NAGE Healthcare Finland OyCCL2022-03-07
10190752111349Vital Signs™Vyaire GmbHCCL2021-04-02
10190752143777Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143784Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143791Vital Signs™AirLife Finland OyCCL2021-03-05
10190752140844Vital Signs™AirLife Finland OyCCL2021-01-28
10190752140912Vital Signs™AirLife Finland OyCCL2021-01-28
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