FDA.reportPublic FDA data

TEC-505-1AS

Primary DI
00853061006715
Brand
TEC-505-1AS
Company
MAXTEC, LLC
Model
T115P10
Device description
Oxygen Sensor
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
K963415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963415000VENTREX OXYGEN SENSORVentrex, LLC1996-11-25CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853061006715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853061006715008530610067158530610067150853061006715

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
169911828
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817770026068Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)R229P18-0012025-07-21
00817770020691HANDI+R218P122016-09-26
00817770020707HANDI+R218P12-0012018-03-27
00817770020868Handi+ R218P12-0052016-09-24
00817770021322HANDI+, OHIO MEDICALR218P12-0122017-02-20
00817770021339HANDI+ INTERNATIONALR218P12-013R218P12-0132017-02-20
00817770024460Dual Hose10' Air/OxygenR129P272021-10-29
00817770022299Coiled Hose15 foot OxygenR127P402021-10-22
00817770024378Dual Hose10' Air/OxygenR129P182021-10-22
00817770024385Dual Hose10' Air/OxygenR129P192021-10-22
00817770024392Dual Hose10' Air/OxygenR129P202021-10-22
00817770024408Dual Hose15' Air/OxygenR129P292021-10-22
00817770024415Dual Hose15' Air/OxygenR129P222021-10-22
00817770024422Dual Hose15' Air/OxygenR129P232021-10-22
00817770024439Dual Hose15' Air/OxygenR129P242021-10-22
00817770024446Dual Hose10' Air/OxygenR129P252021-10-22
00817770024453Dual Hose10' Air/OxygenR129P262021-10-22
00817770024477Dual Hose6' Air/OxygenR129P502021-10-22
00817770024484Dual Hose6' Air/OxygenR129P512021-10-22
00817770024491Dual Hose6' Air/OxygenR129P522021-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCCL2026-04-15
10889483588635Vital Signs™AirLife Finland OyCCL2025-04-02
10889483588659Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
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
00840682146715NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
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