Who else makes this device?

Name: CueSee® Hyperbaric
Brand: CueSee® Hyperbaric

Clinical Chemistry › Test SystemsControls For Blood-Gases, (Assayed And Unassayed)

CueSee® Hyperbaric

CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For…

Registry build 21.09.26

CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For laboratory and near patient (point-of-care) testing by healthcare professionals.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JJS
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for CueSee® Hyperbaric
Listed by	Eurotrol B.V., Netherlands
FDA product code	JJS
Device type	Controls For Blood-Gases, (Assayed And Unassayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2026-01-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 5

Catalogue Numbers

Catalogue numbers for CueSee® Hyperbaric
Catalogue number	Size	Status
1		In distribution

Same Product Code

Other products under the same FDA product code
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Liquichek	Bio-Rad Laboratories Inc.	16
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	11
Architect	Abbott Laboratories	7
Stat Profile	Nova Biomedical Corporation	7
Blood Gas and Electrolyte Control	Edan Instruments, Inc.	3
VKR-7	Radiometer America, Inc.	1
Mission Control, Level 1	Diamond Diagnostics Inc.	1
Autocheck 3+, Level 1, S7335	Radiometer Medical APS	1
Autocheck 3+, Level 4, S7365	Radiometer Medical APS	1
Qualicheck 5+, Level 4	Radiometer Medical APS	1
Qualicheck 5+, Level 3	Radiometer Medical APS	1
QC Adaptor	Radiometer Medical APS	1

Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152553	2016-04-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.