Ameritus ENFit ENF60-KSBA

GUDID 30817522011473

60ml enfit non-sterile amber syringe

KENTEC MEDICAL, INC.

Oral/enteral syringe, single-use
Primary Device ID30817522011473
NIH Device Record Key93bc2278-8ae6-497c-a76d-7ae974be13bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeritus ENFit
Version Model NumberENF60-KSBA
Catalog NumberENF60-KSBA
Company DUNS066175613
Company NameKENTEC MEDICAL, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817522011472 [Unit of Use]
GS110817522011479 [Primary]
GS120817522011476 [Package]
Contains: 10817522011479
Package: box [200 Units]
In Commercial Distribution
GS130817522011473 [Package]
Contains: 10817522011479
Package: case [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNREnteral Syringes With Enteral Specific Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2019-03-28

On-Brand Devices [Ameritus ENFit]

3081752201154160ml enfit non-sterile clear syringe
3081752201153430ml enfit non-sterile clear syringe
3081752201152720ml enfit non-sterile clear syringe
3081752201151010ml enfit non-sterile clear syringe
308175220115035ml enfit low dose non-sterile clear syringe
308175220114973ml enfit low dose non-sterile clear syringe
308175220114801ml enfit low dose non-sterile clear syringe
3081752201147360ml enfit non-sterile amber syringe
3081752201146630ml enfit non-sterile amber syringe
3081752201065020ml enfit non-sterile amber syringe
3081752201064310ml enfit non-sterile amber syringe
308175220106363ml enfit low dose non-sterile amber syringe
308175220106295ml enfit low dose non-sterile amber syringe
308175220106121ml enfit low dose non-sterile amber syringe
30817522013231Enfit syringe cap
308175220131016fr 90cm dual port feeding tube with ENFit connector
308175220123645fr 40cm dual port feeding tube with ENFit connectors
3081752201278460ml enfit enteral feeding syringe
3081752201277730ml enfit enteral feeding syringe
3081752201276020ml enfit enteral feeding syringe
3081752201275310ml enfit enteral feeding syringe
308175220127465ml enfit enteral feeding syringe-low dose
308175220127393ml enfit enteral feeding syringe-low dose
308175220127221ml enfit enteral feeding syringe-low dose
308175220123578fr 80cm single port feeding tube with ENFit connector

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