Actril Indicator Test Strips

GUDID 10677964105972

MEDIVATORS INC.

Organic peroxy acid device sterilant, single-use
Primary Device ID10677964105972
NIH Device Record Keyadcd3d92-88f6-49d1-93df-02598fdbdde3
Commercial Distribution StatusIn Commercial Distribution
Brand NameActril Indicator Test Strips
Version Model Number78280-000
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count100
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964105975 [Unit of Use]
GS110677964105972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKQSystem, Dialysate Delivery, Central Multiple Patient

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-11-02
Device Publish Date2018-12-04

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