FDA.report

Revital-Ox Resert

Primary DI
50724995000788
Brand
Revital-Ox Resert
Company
STERIS CORPORATION
Model
4455N9
Catalog number
4455N9
Device description
Revital-Ox Resert is a high Level disinfectant with a 21 day reuse solution. This product is designed to disinfect cleaned, reusable, semi-critical, heat labile medical devices. It has both a manual and automated reprocessing use. It must be used with Revital-Ox RESERT R60 Solution Test Strips.
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MEDSterilant, medical devices

Product Code Classifications

CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50724995000788PackageGS16In Commercial Distribution
00724995000783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499500078850724995000788
00724995000783007249950007837249950007830724995000783

GMDN Terms

TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Device Sizes

TypeValueUnit
Total Volume1Liter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep in original container
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
139424188
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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