FDA.reportPublic FDA data

Invacare® Oxygen Analyzer

Primary DI
00841447100737
Brand
Invacare® Oxygen Analyzer
Company
INVACARE CORPORATION
Model
IRC450
Published
2017-03-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K112402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112402000ULTRAMAXO2 OXYGEN ANALYERMaxtec, LLC2011-12-14CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841447100737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100737008414471007378414471007370841447100737

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen monitor, line-poweredA mains electricity (AC-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; it may also include appropriate temperature-compensated electrodes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(440)329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841447116431Invacare® Alternating Air Mattress & PumpMA101BLMA101BL2026-05-01
00841447116448Invacare® Alternating Air Mattress & PumpMA101BKMA101BK2026-05-01
00841447116455Invacare® Alternating Air Mattress & Pump with Static ModeMA102BLMA102BL2026-05-01
00841447116462Invacare® Alternating Air Mattress & Pump with Static ModeMA102BKMA102BK2026-05-01
00841447116479Easy Glide Transport Chair for InvacareEGTC19STFSBUEGTC19STFSBU2026-04-10
00841447116486Easy Glide Transport Chair for InvacareEGTC19STFSBKEGTC19STFSBK2026-04-10
00841447116493Easy Glide Transport Chair for InvacareEGTC19STRSBUEGTC19STRSBU2026-04-10
00841447116509Easy Glide Transport Chair for InvacareEGTC19STRSBKEGTC19STRSBK2026-04-10
00841447116516Easy Glide Transport Chair for InvacareEGTC19ALRSBUEGTC19ALRSBU2026-04-10
00841447116523Easy Glide Transport Chair for InvacareEGTC19ALRSBKEGTC19ALRSBK2026-04-10
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13
00841447116387Easy Glide Wheelchair for InvacareEGWC20STRSBUEGWC20STRSBU2026-02-13

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