| Primary Device ID | 00819989014904 |
| NIH Device Record Key | 2f8d7b4a-f701-4c5e-a4e1-ffc7a8dfd41d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BVF22 Bacteria Filter |
| Version Model Number | BVF22 |
| Company DUNS | 825179992 |
| Company Name | EXCELERON MEDICAL, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00819989014904 [Primary] |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 00819989014928 - HME Filter | 2021-08-05 Heat Moisture Exchanger, O2 configuration |
| 00819989014911 - HME Filter | 2021-08-03 Heat Moisture Exchanger, T configuration |
| 10819989011184 - CPAP Tubing | 2021-06-01 CPAP Tubing, 18 inch, single-pack |
| 00819989011002 - CPAP Tubing | 2020-10-02 CPAP Tubing, 1 ft, single pack |
| 00819989014904 - BVF22 Bacteria Filter | 2020-10-02BVF22 Bacteria Filter |
| 00819989014904 - BVF22 Bacteria Filter | 2020-10-02 BVF22 Bacteria Filter |
| 00812970012002 - Nuwave | 2020-10-01 NUWAVE Generator |
| 00812970012019 - Nuwave | 2020-10-01 NUWAVE with Small Bag |
| 00812970012026 - Nuwave | 2020-10-01 NUWAVE with Large Bag |