Suction Catheter Kit TRATK108

GUDID 00848530082062

This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most.

SUNSET HEALTHCARE SOLUTIONS, INC.

Tracheostomy suction kit
Primary Device ID00848530082062
NIH Device Record Key598c5fca-be6b-4d55-8eed-df097095044d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuction Catheter Kit
Version Model NumberTRATK108
Catalog NumberTRATK108
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530082062 [Primary]
GS110848530082069 [Package]
Package: [50 Units]
In Commercial Distribution
GS120848530082066 [Package]
Contains: 10848530082069
Package: [4 Units]
In Commercial Distribution

FDA Product Code

OFSTracheal Suction Set

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-31
Device Publish Date2018-07-31

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