Primary Device ID | B040CPIM26 |
NIH Device Record Key | 16cbfb8a-6e04-478e-a283-1f2d09fa40d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Heart Chill Cardiac & Phrenic Insulator |
Version Model Number | CPI-M |
Company DUNS | 939872651 |
Company Name | GENESEE BIOMEDICAL, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 800 786-4890 |
info@geneseebiomedical.com | |
Phone | 800 786-4890 |
info@geneseebiomedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B040CPIM15 [Primary] |
HIBCC | B040CPIM26 [Package] Contains: B040CPIM15 Package: [1 Units] In Commercial Distribution |
DWC | Controller, Temperature, Cardiopulmonary Bypass |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-02-01 |
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B040WF30 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
B040WF32 - WellsFormTricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
B040WF34 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
B040WF360 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
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B040420028 - NeoForm | 2019-05-30 Annuloplasty Ring |