Who else makes this device?

Name: 925-047 ABL90 Flex inlet clip
Brand: 925-047 ABL90 Flex inlet clip

Hematology › Automated Hematology DevicesSystem, Hemoglobin, Automated

925-047 ABL90 Flex Inlet Clip

ABL90 FLEX Inlet Clip to attach to ABL90 inlet

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GKR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29

Record

Regulatory record for 925-047 ABL90 Flex inlet clip
Listed by	Radiometer Medical APS, Denmark
FDA product code	GKR
Device type	System, Hemoglobin, Automated
Device class	Class 2
Regulation	21 CFR 864.5620
Establishment	Complaint-file establishment, Manufacturer
Record published	2018-09-21
Record revised	2022-09-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only

Catalogue Numbers

Catalogue numbers for 925-047 ABL90 Flex inlet clip
Catalogue number	Size	Status
925-047		In distribution

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Mission Plus Hemoglobin (Hb) Monitoring System	Acon Laboratories, Inc.	3
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HemoCue® Hb 201+ Analyzer	Hemocue AB	2
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Mission Plus Hemoglobin (Hb) Optical Verifier	Acon Laboratories, Inc.	2
HemoCue® Hb301 Analyzer	Hemocue AB	2

Showing 12 of 43. All products under System, Hemoglobin, Automated

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.