FDA.reportPublic FDA data

CueSee® Hypoxic

Primary DI
08718734960669
Brand
CueSee® Hypoxic
Company
Eurotrol B.V.
Model
CueSee® Hypoxic X-Low
Catalog number
166.001.005
Device description
CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).
Published
2020-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JJSControls For Blood-Gases, (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152553000CueSee HypoxicEurotrol B.V.2016-04-22JJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734960669PackageGS15In Commercial Distribution
08718734960652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734960669087187349606698718734960669
08718734960652087187349606528718734960652

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
412925992
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
08718734962724CueSee® Coag1340.001.0052025-04-08
08718734962731CueSee® Coag2340.002.0052025-04-08
08718734962748CueSee® Coag3340.003.0052025-04-08
08718734962755CueSee® Coag4340.004.0052025-04-08
08718734962762CueSee® Coag5340.005.0052025-04-08
08718734963035CueSee® Hyperbaric1350.001.0052026-01-07
08718734963042CueSee® Hyperbaric1350.001.0052026-01-07
08718734960621Eurotrol AlbuTrolAlbuTrol Level 1189.001.0022020-10-08
08718734960645Eurotrol AlbuTrolAlbuTrol Level 2189.002.0022020-10-08
08718734962946CueSee® BGEM1344.001.0052025-07-25
08718734962953CueSee® BGEM2344.002.0052025-07-25
08718734962960CueSee® BGEM3344.003.0052025-07-25
08718734962991CueSee® BGEM1344.001.0052025-07-25
08718734963004CueSee® BGEM2344.002.0052025-07-25
08718734963011CueSee® BGEM3344.003.0052025-07-25
08718734963028CueSee® BGEM1 2 3 4 5345.000.0052025-07-25
08718734962779CueSee® Coag1340.001.0052025-04-08
08718734962786CueSee® Coag2340.002.0052025-04-08
08718734962793CueSee® Coag3340.003.0052025-04-08
08718734962809CueSee® Coag4340.004.0052025-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718734963035CueSee® HyperbaricEurotrol B.V.JJS2026-01-07
08718734963042CueSee® HyperbaricEurotrol B.V.JJS2026-01-07
00380740153694AlinityABBOTT LABORATORIESJJS2023-10-14
10852676007121Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007138Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007145Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007152Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007169Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007176Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007183Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007190Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007206Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007213Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007114Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007124Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007131Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007148Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007155Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007162Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007179Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007186Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007193Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007209Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007216Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00811403014743Mission Control, Level 1Diamond Diagnostics Inc.JJS2023-06-05
00811403014750Mission Control, Level 2Diamond Diagnostics Inc.JJS2023-06-05
00811403014767Mission Control, Level 3Diamond Diagnostics Inc.JJS2023-06-05
00811403014781Mission Control, Level 1-2-3Diamond Diagnostics Inc.JJS2023-06-05
05700699252142QC AdaptorRadiometer Medical ApSJJS2022-12-08
05700699440174QUALICHECK 5+, LEVEL 1Radiometer Medical ApSJJS2022-12-05