Vesco Medical ENFit Tip Syringe VED-660

GUDID 10850801006315

60 mL ENFit Tip Syringe - Blister Pack

VESCO MEDICAL, LLC

ENFit oral/enteral syringe, single-use
Primary Device ID10850801006315
NIH Device Record Key08c59fd9-e75a-4bbf-a319-dd468fa319db
Commercial Distribution StatusIn Commercial Distribution
Brand NameVesco Medical ENFit Tip Syringe
Version Model NumberVED-660
Catalog NumberVED-660
Company DUNS079527070
Company NameVESCO MEDICAL, LLC
Device Count1
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com

Device Dimensions

Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter

Operating and Storage Conditions

Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850801006318 [Primary]
GS110850801006315 [Package]
Contains: 00850801006318
Package: Case [180 Units]
In Commercial Distribution
GS120850801006312 [Package]
Contains: 00850801006318
Package: Inner Pack [30 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

On-Brand Devices [Vesco Medical ENFit Tip Syringe]

1085080100654460 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
1085080100652020 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
1085080100651310 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
1085080100635335 mL ENFit Tip Syringe - Blister Pack
2085080100634320 mL ENFit Tip Syringe - Blister Pack
1085080100633910 mL ENFit Tip Syringe - Blister Pack
008508010063255 mL ENFit Tip Syringe - Blister Pack
1085080100631560 mL ENFit Tip Syringe - Blister Pack
108100961506295 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector

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