CORFLO Safety PEG Kit 50-6316

GUDID 20815149021656

PEG Kit with ENFit Connectors Pull Technique

CORPAK MEDSYSTEMS, INC.

Gastrostomy tube
Primary Device ID20815149021656
NIH Device Record Key50e2c6f0-e848-4b9b-8a01-b37545df3d2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORFLO Safety PEG Kit
Version Model Number50-6316
Catalog Number50-6316
Company DUNS147530323
Company NameCORPAK MEDSYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(847)403-3400
Emailquestions@corpak.com

Device Dimensions

Catheter Gauge16 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No

Device Identifiers

Device Issuing AgencyDevice ID
GS110815149021659 [Primary]
GS120815149021656 [Package]
Contains: 10815149021659
Package: [2 Units]
In Commercial Distribution

FDA Product Code

KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20815149021656]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2016-06-24

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