Primary Device ID | 00847713000589 |
NIH Device Record Key | dceff118-5e9a-4c5d-90e4-a2f736a03459 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | microdot® |
Version Model Number | 1000-100 |
Company DUNS | 962314360 |
Company Name | Cambridge Sensors USA 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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847713000572 [Primary] |
GS1 | 00847713000589 [Package] Contains: 00847713000572 Package: Case [100 Units] In Commercial Distribution |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-09 |
Device Publish Date | 2023-05-01 |
00847713000985 - microdot® Pro Gloves | 2025-02-26 Microdot® Pro Nitrile Small Gloves |
00847713000992 - microdot® Pro Gloves | 2025-02-26 Microdot® Pro Nitrile Medium Gloves |
00847713001005 - microdot® Pro Gloves | 2025-02-26 microdot® Pro Nitrile Large Gloves |
00847713001012 - microdot® Pro Gloves | 2025-02-26 microdot® Pro Nitrile X-Large Gloves |
00847713001029 - microdot® Pro Gloves | 2025-02-26 microdot® Pro Nitrile XX-Large Gloves |
00847713000800 - microdot® Pro Test Strips (25ct) | 2024-11-07 microdot® Pro Test Strips (25ct) |
00847713000817 - microdot® Pro Test Strips (50ct) | 2024-11-07 microdot® Pro Test Strips (50ct) |
00847713000787 - microdot® Pro Glucometer | 2024-10-30 microdot® Pro Glucometer |