| Primary Device ID | 00810008217818 |
| NIH Device Record Key | f6e1c858-7c89-49cd-83bc-84b0db97c727 |
| 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 | 00810008217801 [Primary] |
| GS1 | 00810008217818 [Package] Contains: 00810008217801 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 |
| 00810008217795 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217771 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216347 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216323 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217818 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217917 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217894 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217870 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217856 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008217832 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216460 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216446 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216422 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216408 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |
| 00810008216385 | The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin |