FDA.reportPublic FDA data

Analytical Industries Inc.

Primary DI
00897772002246
Brand
Analytical Industries Inc.
Company
ANALYTICAL INDUSTRIES INC.
Model
PSR-11-77
Device description
Oxygen Sensor
Published
2017-01-13
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
00897772002246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897772002246008977720022468977720022460897772002246

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04036616011983Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-27
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
04036616011969Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011976Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616013482Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
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