Primary Device ID | G292590 |
NIH Device Record Key | 94f4e9f7-1fd2-4125-97ed-8dda8ccbe5c6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Capillary Blood Specimen Collection Supplemental Pack |
Version Model Number | 1 |
Company DUNS | 809047215 |
Company Name | Biodesix, 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 | true |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G292590 [Primary] |
PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-04 |
Device Publish Date | 2023-07-27 |
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