TravelKit Contains - First Step Kit and Soiled Scope Bag

GUDID 30843356100908

TravelKit Contains - First Step Kit (200ml EP-4 Kit) and Soiled Scope Bag - 50 Each

CYGNUS MEDICAL L.L.C.

Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit Endoscopy preparation kit
Primary Device ID30843356100908
NIH Device Record Keycfccb3bd-544b-4e85-bbb7-a09cda4c007d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTravelKit Contains - First Step Kit and Soiled Scope Bag
Version Model NumberTK200
Company DUNS103169095
Company NameCYGNUS MEDICAL L.L.C.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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
GS100843356100907 [Primary]
GS130843356100908 [Unit of Use]

FDA Product Code

MNLAccessories, Cleaning Brushes, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

Devices Manufactured by CYGNUS MEDICAL L.L.C.

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10843356102700 - Air Time 2024-02-09 AIRTIME™ HORIZONTAL DRYING, DIRECTIONAL FLOW TUBING SET. USED FOR DRYING COILED SCOPES. 4 TUBING PORTS
30843356100649 - SingleCycle Biohazard Self-Sealing label 20" 2023-12-08 SingleCycle Biohazard Self-Sealing label 20" 500 per case
30843356102391 - SingleCycle Biohazard Self-Sealing label 15" 2023-12-08 SingleCycle Biohazard Self-Sealing label 15" 500 per case

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