FDA.reportPublic FDA data

Choice

Primary DI
00817770020592
Brand
Choice
Company
MAXTEC, LLC
Model
R204P23-001
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817770020592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817770020592008177700205928177700205920817770020592

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
169911828
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00817770025665Oxygen SensorMax-250E ExternalR125P03-1022024-08-14
00817770025849AnalyzerMaxO2+R219P20-0092024-08-14
00817770025856MaxBlend2High FlowR229P02-0102024-08-14
00817770025863ManifoldFlowmeterR220P01-0152024-08-14
00817770025870ManifoldFlowmeterR220P01-1142024-08-14
00817770025931AnalyzerMaxO2+R233P04-0052024-08-14
00817770025948AnalyzerMaxO2+R217P62-0082024-08-14
00817770025955ManifoldFlowmeterR220P01-1152024-08-14
10817770021121SmartStackR100P49-0082019-01-14
00817770020561EyeMax2KitR300P162023-06-12
00817770020974Flowmeter0-70 LPM1MFA8001AUMX2023-06-12
00817770025818EyeMax2MicroR300P03-0042023-06-12
00817770025825EyeMax2PreemieR300P02-0042023-06-12
00817770025832EyeMax2RegularR300P01-0042023-06-12
00817770022213SmartStackBundleR100P902023-06-08
00817770022220SmartStackBundleR100P90-0012023-06-08
00817770022374MicroBlenderLow Flow NISTR219P24-0022023-06-08
00817770022442BlenderBuddyTenacoreR219P512023-06-08
00817770023920Flowmeter ManifoldIV PoleR220P532023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521091986NellcorCovidien LPDQA2026-05-25
06946725571460APKAPK Technology Co.,Ltd.DQA2026-05-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19