FDA.reportPublic FDA data

Analytical Industries Inc.

Primary DI
00897772002017
Brand
Analytical Industries Inc.
Company
ANALYTICAL INDUSTRIES INC.
Model
AII-2000M
Device description
Oxygen Monitor
Published
2017-01-18
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
K053407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053407000OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000MAnalytical Industries, Inc.2006-04-05CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00897772002017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897772002017008977720020178977720020170897772002017

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen monitor, battery-poweredA battery-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.

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
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
00897772002239Analytical Industries Inc.PSR-11-917-MH2017-01-10

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Primary DI, Brand, Company table
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00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCCL2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
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00840682147217NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
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
10190752141827Vital Signs™AirLife Finland OyCCL2021-01-28