ONE-CARE Pen Needles 3019

GUDID 00810008211656

Insulin syringe/needle, safety

Primary Device ID	00810008211656
NIH Device Record Key	36a9a3f4-69da-44ee-8c5c-c525090f5035
Commercial Distribution Status	In Commercial Distribution
Brand Name	ONE-CARE Pen Needles
Version Model Number	3019-ONE-CARE Pen Needles 31G x 8mm, Orange, 100/b
Catalog Number	3019
Company DUNS	080740980
Company Name	MediVena, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00810008211625 [Primary]
GS1	00810008211656 [Package] Contains: 00810008211625 Package: case [50 Units] In Commercial Distribution

FMI	Needle, Hypodermic, Single Lumen

Steralize Prior To Use	false
Device Is Sterile	true

00810008211632	The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008215531	The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008211175	The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008211656	he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin