FDA.reportPublic FDA data

COECIDE™ XL

Primary DI
D6585511281
Brand
COECIDE™ XL
Company
Gc America Inc.
Model
551128
Catalog number
551128
Device description
COECIDE™ XL 1 gallon liquid with 158g activator
Published
2016-08-01
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
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931052000METRICIDE 28Metrex Research Corp.1994-12-06MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6585511282PackageHIBCC4In Commercial Distribution
D6585511281PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device-decontamination agentA non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
10386040013437EXA Advanced1381121381122022-08-12
10386040013444EXA Advanced1381131381132022-08-12
10386040013451EXA Advanced1381161381162022-08-12
10386040013468EXA Advanced1381171381172022-08-12
10386040013475EXA Advanced1381181381182022-08-12
10386040013482EXA Advanced1381191381192022-08-12
10386040013871EQUIA®4520034520032022-07-13
D6581200011COE ALGINATE™1200011200012016-08-01
D6581201011COE ALGINATE™1201011201012016-08-01
D6581210011COE ALGINATE™1210011210012016-08-01
D6581211011COE ALGINATE™1211011211012016-08-01
D6581240011COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241011COE HYDROPHILIC GEL™1241011241012016-08-01
D6581310021COE-FLEX®1310021310022016-08-01
D6581310031COE-FLEX®1310031310032016-08-01
D6581310041COE-FLEX®1310041310042016-08-01

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