Primary Device ID | 00810008216361 |
NIH Device Record Key | cd99840c-524b-40c4-9cc7-2538979012c3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GLUCO-CARE Pen Needles, |
Version Model Number | 3037-GLUCO-CARE Pen Needles, 31G x 5mm, Purple, 10 |
Catalog Number | 3037 |
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 |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com | |
Phone | 4045142586 |
info@medivena.com |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
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 | 00810008216354 [Primary] |
GS1 | 00810008216361 [Package] Contains: 00810008216354 Package: case [50 Units] In Commercial Distribution |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-18 |
Device Publish Date | 2025-03-10 |
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 |