Primary Device ID | 20851221006081 |
NIH Device Record Key | 0f877755-673a-4a86-8543-ad57af60a511 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NC-stat DPNCheck |
Version Model Number | NC-DP2 |
Catalog Number | DB-025, DB-050 |
Company DUNS | 957536014 |
Company Name | NEUROMETRIX, INC. |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 781-314-2781 |
rainer_maas@neurometrix.com |
Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851221006087 [Primary] |
GS1 | 10851221006084 [Package] Contains: 00851221006087 Package: Case [25 Units] In Commercial Distribution |
GS1 | 20851221006081 [Package] Contains: 00851221006087 Package: Case [50 Units] In Commercial Distribution |
JXE | Device, Nerve Conduction Velocity Measurement |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-10-22 |
Device Publish Date | 2016-12-01 |
00851221006261 | NC-stat DPNCheck Device |
20851221006081 | NC-stat DPNCheck Biosensor DB-025 = QTY 25 OF NC-DP2 DB-050 = QTY 50 OF NC-DP2 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NC-STAT DPNCHECK 88802832 not registered Live/Pending |
NeuroMetrix, Inc. 2020-02-19 |