| Primary Device ID | 50382902005006 |
| NIH Device Record Key | da43c278-61b4-4c7c-9b30-6086b3a5df29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD SmartSite Bag 500mL |
| Version Model Number | 11365-325-04 |
| Catalog Number | 200500 |
| Company DUNS | 158233937 |
| Company Name | Gilero, LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382902005001 [Primary] |
| GS1 | 50382902005006 [Package] Contains: 00382902005001 Package: Shipper [125 Units] In Commercial Distribution |
| KPE | Container, I.V. |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-11 |
| Device Publish Date | 2023-12-01 |
| 00382902001003 - BD SmartSite Bag 100mL | 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a |
| 50382902002500 - BD SmartSite Bag 250mL | 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a |
| 50382902005006 - BD SmartSite Bag 500mL | 2023-12-11The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. |
| 50382902005006 - BD SmartSite Bag 500mL | 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a |
| 00850025535502 - UTC 3ml Medication Cartridge | 2023-10-03 UTC 3mL Medication Cartridge: The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments |
| 00850025535991 - NUM Vapocoolant | 2021-06-14 NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain as |