ONE-CARE OPTI Safety Lancets 1037

GUDID 00810008212042

Manual blood lancing device, single-use

Primary Device ID	00810008212042
NIH Device Record Key	dae1d7f5-2106-40a3-af35-47ba7108c16f
Commercial Distribution Status	In Commercial Distribution
Brand Name	ONE-CARE OPTI Safety Lancets
Version Model Number	ONE-CARE OPTI Safety Lancets Top Button Activated,
Catalog Number	1037
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	true
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	00810008211977 [Primary]
GS1	00810008212042 [Package] Contains: 00810008211977 Package: case [18 Units] In Commercial Distribution

FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Steralize Prior To Use	false
Device Is Sterile	true

00810008212172	ONE-CARE OPTI Safety Lancets Top Button Activated, are sterile, single-use devices designed for
00810008212158	ONE-CARE OPTI Safety Lancets Top Button Activated, are sterile, single-use devices designed for
00810008212042	ONE-CARE OPTI Safety Lancets Top Button Activated, are sterile, single-use devices designed for
00810008212035	ONE-CARE OPTI Safety Lancets Top Button Activated, are sterile, single-use devices designed for
00810008212011	ONE-CARE OPTI Safety Lancets Top Button Activated, are sterile, single-use devices designed for