Vesco Medical ENFit Low Dose Tip Syringe VED-603EO

GUDID 20850801006398

3 mL ENFit Low Dose Tip Syringe

VESCO MEDICAL, LLC

Oral/enteral syringe, single-use
Primary Device ID20850801006398
NIH Device Record Key2558a2b4-f388-42c8-88df-1871c4c1ac25
Commercial Distribution StatusIn Commercial Distribution
Brand NameVesco Medical ENFit Low Dose Tip Syringe
Version Model NumberVED-603EO
Catalog NumberVED-603EO
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
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com
Phone6149145991
Emailinfo@vescomedical.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 120 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
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
GS100850801006394 [Primary]
GS110850801006391 [Package]
Contains: 00850801006394
Package: Inner Pack [200 Units]
In Commercial Distribution
GS120850801006398 [Package]
Contains: 10850801006391
Package: Case [4 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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-22
Device Publish Date2017-10-05

On-Brand Devices [Vesco Medical ENFit Low Dose Tip Syringe]

208508010063983 mL ENFit Low Dose Tip Syringe
208508010063811 mL ENFit Low Dose Tip Syringe

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