FDA.reportPublic FDA data

Criterion OxiCheck

Primary DI
00884838083189
Brand
Criterion OxiCheck
Company
Respironics Novametrix, LLC
Model
00
Catalog number
8-100661-00
Published
2017-10-06
Public version status
Update
Distribution status
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
K023565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023565000OXICHECKCaradyne, Ltd.2003-03-28CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838083189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838083189008848380831898848380831890884838083189

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(203)697-6450OEM.RESPIRONICS@PHILIPS.COM

Regulatory Flags#

DUNS number
093608594
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838104723Airway Adapters114946611494662023-11-15
00884838104730Airway Adapters114933911493392023-11-15
00884838104761Airway Adapters114938111493812023-11-15
00884838104778Airway Adapter114938311493832023-11-15
00884838104785Airway Adapters114938611493862023-11-15
00884838104792Airway Adapters114944811494482023-11-15
00884838104884LoFlo Accessories114948011494802023-11-15
00884838104891LoFlo Accessories114948211494822023-11-15
00884838104907LoFlo Accessories114948311494832023-11-15
00884838104938LoFlo Accessories114937911493792023-11-15
00884838104945LoFlo Accessories114948811494882023-11-15
00884838104952Airway Adapters114948911494892023-11-15
00884838104969Airway Adapters114949011494902023-11-15
00884838104976Airway Adapters114949111494912023-11-15
00884838104983Airway Adapters114949211494922023-11-15
00884838105584Flow Sensor114990311499032023-11-15
00884838105607Flow Sensor114990511499052023-11-15
00884838105614Airway Adapters114994811499482023-11-15
00884838105621Airway Adapters114994211499422023-11-15
00884838104662Capnostat 5 114932111493212023-11-14

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Primary DI, Brand, Company table
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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