ONE-CARE PLUS Safety Pen Needles 3104

GUDID 00810008217658

Autoinjector needle

Primary Device ID	00810008217658
NIH Device Record Key	d297ac18-22d5-43f7-99fc-0eea0c91e650
Commercial Distribution Status	In Commercial Distribution
Brand Name	ONE-CARE PLUS Safety Pen Needles
Version Model Number	3104-ONE-CARE PLUS Safety Pen Needles 30G x 8mm,
Catalog Number	3104
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

Device Issuing Agency	Device ID
GS1	00810008217641 [Primary]
GS1	00810008217658 [Package] Contains: 00810008217641 Package: case [20 Units] In Commercial Distribution

FMI	Needle, Hypodermic, Single Lumen

Steralize Prior To Use	false
Device Is Sterile	true

00810008211540 - ONE-CARE Pen Needles,	2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp
00810008211656 - ONE-CARE Pen Needles	2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp
00810008216385 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216408 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216422 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216446 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216460 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008217832 - GLUCO-CARE Pen Needles	2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com