Synermed®

Primary DI: 05060500090654
Brand: Synermed®
Company: INFRARED LABORATORY SYSTEMS LLC
Model: UV380-WK
Catalog number: UV380-WK
Device description: CO2 Reagent 3 X 50 mL + 3 powder wedges
Published: 2016-09-20
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

irlabsystems.com

Product Codes

Code	Name
KHS	Enzymatic, Carbon-Dioxide

Product Code Classifications

Code	Device	Specialty	Class
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
05060500090654	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
05060500090654	05060500090654	5060500090654

GMDN Terms

Term	Definition
Carbon dioxide (CO2) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	0 Degrees Celsius	4 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
317 896-1565	info@irlabsystems.com

Regulatory Flags

DUNS number: 014210494
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
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	Catalog	Published
05060500090005	Synermed®	IR-500	IR-500	2016-09-20
05060500090012	Synermed®	IR-1200	IR-1200	2016-12-12
05060500090029	Synermed®	IR010-R	IR010-R	2016-09-20
05060500090036	Synermed®	IR010-X	IR010-X	2016-09-20
05060500090043	Synermed®	IR010-WK	IR010-WK	2016-09-20
05060500090050	Synermed®	IR010-911	IR010-911	2016-09-20
05060500090067	Synermed®	IR010-L	IR010-L	2016-09-20
05060500090074	Synermed®	VI120-R	VI120-R	2016-09-20
05060500090081	Synermed®	VI120-X	VI120-X	2016-09-20
05060500090098	Synermed®	VI120-WK	VI120-WK	2016-09-20
05060500090104	Synermed®	VI120-911	VI120-911	2016-09-20
05060500090111	Synermed®	VI121-L	VI121-L	2016-09-20
05060500090128	Synermed®	VI400-R	VI400-R	2016-09-20
05060500090135	Synermed®	VI400-X	VI400-X	2016-09-20
05060500090142	Synermed®	VI400-WK	VI400-WK	2016-09-20
05060500090159	Synermed®	VI400-911	VI400-911	2016-09-20
05060500090166	Synermed®	VI400-R	VI400-R	2016-09-20
05060500090173	Synermed®	UV185-R	UV185-R	2016-09-20
05060500090180	Synermed®	UV185-X	UV185-X	2016-09-20
05060500090197	Synermed®	UV185-WK	UV185-WK	2016-09-20

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07613336121146	Bicarbonate Liquid	Roche Diagnostics GmbH	KHS	2020-03-05
00380740161545	ARCHITECT	Abbott GmbH & Co. KG	KHS	2020-01-25
00380740161521	ARCHITECT	Abbott GmbH & Co. KG	KHS	2020-01-04
00380740161538	ARCHITECT	Abbott GmbH & Co. KG	KHS	2020-01-04
00386100002053	CO2 Reagent Kit	MEDICA CORPORATION	KHS	2019-02-14
00380740121594	Alinity	Abbott GmbH & Co. KG	KHS	2018-08-31
00380740121600	Alinity	Abbott GmbH & Co. KG	KHS	2018-08-08
00852169008072	ClearChem Diagnostics Inc. Carbon Dioxide (CO2)	CLEARCHEM DIAGNOSTICS INC.	KHS	2018-04-30
00630414595900	Atellica CH CO2_c	Siemens Healthcare Diagnostics Inc.	KHS	2017-12-22
00845275000047	Thermo Scientific Infinity™	Fisher Diagnostics	KHS	2017-06-22
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00817274022498	JAS Diagnostics	DREW SCIENTIFIC, INC.	KHS	2017-04-10
00817089020047	Diazyme	DIAZYME LABORATORIES, INC.	KHS	2016-11-03
00817089020054	Diazyme	DIAZYME LABORATORIES, INC.	KHS	2016-11-03
00812137011947	Carbon Dioxide Reagent	CLINICAL DIAGNOSTIC SOLUTIONS, INC.	KHS	2016-10-12
15099590010348	AU	Beckman Coulter, Inc.	KHS	2016-09-24
15099590020187	AU	Beckman Coulter, Inc.	KHS	2016-09-24
15099590060206	AU	Beckman Coulter, Inc.	KHS	2016-09-24
00842768005374	Dimension® Flex® reagent cartridge EC02	Siemens Healthcare Diagnostics Inc.	KHS	2016-09-24
00842768015625	Dimension Vista® Flex® reagent cartridge CO2	Siemens Healthcare Diagnostics Inc.	KHS	2016-09-24
00857969006150	ACE	ALFA WASSERMANN, INC.	KHS	2016-09-24
00630414498928	ADVIA® Chemistry CO2_L Reagents (Liquid)	Siemens Healthcare Diagnostics Inc.	KHS	2016-09-24
00630414505497	ADVIA® Chemistry CO2_L Carbon Dioxide Liquid Reagents	Siemens Healthcare Diagnostics Inc.	KHS	2016-09-24
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