Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa

GUDID 10843356101789

Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Water Bowl, 10X 4X4 GAUZE AND 2 OZ LUBE, 1 Kit

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 Endoscopy preparation kit
Primary Device ID10843356101789
NIH Device Record Key0d6469e4-d18d-47dd-a8f1-9edde733d67d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa
Version Model NumberBNK-T-BBHJ-PAD-M
Company DUNS103169095
Company NameCYGNUS MEDICAL L.L.C.
Device Count1
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
GS100843356101782 [Primary]
GS110843356101789 [Package]
Contains: 00843356101782
Package: [25 Units]
In Commercial Distribution

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 Date2022-04-08
Device Publish Date2022-03-31

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