Rapicide High Level Disinfectant and Sterilant

GUDID 30677964034856

MEDIVATORS INC.

Glutaraldehyde device sterilant
Primary Device ID30677964034856
NIH Device Record Key99e84bf8-3796-42eb-baea-2385a378713c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapicide High Level Disinfectant and Sterilant
Version Model NumberML02-0059
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964034855 [Primary]
GS130677964034856 [Package]
Contains: 00677964034855
Package: Box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

Devices Manufactured by MEDIVATORS INC.

50677964150550 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze, Duosw
50677964150567 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Basin, Sponge, Defendo Pentax 4-piece Kit, Transport Pad, Lubricant, Gauze, and Biohazard
50677964150574 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Basin, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze
50677964150581 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Basin, Enzymatic Sponge, Fuji 700 4-piece kit, Drawstring Pad, Lubricant, Gauze, Dirty Sc
50677964150598 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Sponge, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauz
50677964150604 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Transport Pad, Lubricant, Gauze, Duosw
50677964150611 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Basin, Sponge, Transport Pad, Gauze, Lubricant, Double Header Combination Channel Valve B
50677964150628 - Custom Procedure Kit2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo 5-piece Olympus Kit, Drawstring Pad, Gauze, Lubricant, Dou

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.