Primary Device ID | 00811403011742 |
NIH Device Record Key | 7a55c237-2e46-4075-9720-1e091bd52cbf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ISE Reference Solution Kit |
Version Model Number | BT-6620941D |
Company DUNS | 947514303 |
Company Name | Diamond Diagnostics Inc. |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811403011742 [Unit of Use] |
GS1 | 00811403011759 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-20 |
Device Publish Date | 2023-06-12 |
00811403010158 - Photometer Lamp | 2023-06-21 |
00811403010240 - Reference Solution | 2023-06-21 |
00811403013074 - Pump Tubing Kit | 2023-06-21 |
00811403013173 - C1/C2 Cleaning Solution | 2023-06-21 |
00811403010387 - Wash Pack | 2023-06-21 |
00811403013296 - pH Electrode | 2023-06-21 |
00811403013302 - Calcium Electrode | 2023-06-21 |
00811403013319 - Potassium Electrode | 2023-06-21 |