| Primary Device ID | 38051736003769 |
| NIH Device Record Key | b2ab957e-f860-4688-8ca5-8324c6c14058 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3 L NON STERILE WASTE BAGS |
| Version Model Number | IB0507009 |
| Company DUNS | 338685723 |
| Company Name | BELLCO SRL |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 364 Millimeter |
| Width | 210 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08051736003768 [Primary] |
| GS1 | 10884521816732 [Unit of Use] |
| GS1 | 38051736003769 [Package] Contains: 08051736003768 Package: CASE [20 Units] In Commercial Distribution |
| BTC | BAG, RESERVOIR |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-12 |
| Device Publish Date | 2021-05-30 |
| 68051736007041 - CLEARUM HS | 2023-08-14 CLEARUM HS 17 High Flux dialyzer |
| 08051736003652 - CARPEDIEM | 2023-07-14 CARPEDIEM |
| 38051736003769 - 3 L NON STERILE WASTE BAGS | 2023-07-123 L NON STERILE WASTE BAGS |
| 38051736003769 - 3 L NON STERILE WASTE BAGS | 2023-07-12 3 L NON STERILE WASTE BAGS |
| 38032979792290 - CARPEDIEM | 2022-02-09 BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM |
| 38032979792283 - CARPEDIEM | 2022-01-31 BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM |
| 68051736004132 - CLEARUM HS | 2021-01-11 CLEARUM HS 13 High Flux dialyzer |
| 68051736004149 - CLEARUM HS | 2021-01-11 CLEARUM HS 15 High Flux dialyzer |
| 68051736004156 - CLEARUM HS | 2021-01-11 CLEARUM HS 17 High Flux dialyzer |