Primary Device ID | 20385540109722 |
NIH Device Record Key | 5131f7f4-08a0-4016-9807-8127740f73fa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CareSens S Fit |
Version Model Number | 8000-10972 |
Company DUNS | 156756129 |
Company Name | AGAMATRIX, 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 | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00385540109728 [Primary] |
GS1 | 20385540109722 [Package] Contains: 00385540109728 Package: Shipper [12 Units] In Commercial Distribution |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-12 |
Device Publish Date | 2025-08-04 |
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