| Primary Device ID | 00303786986019 |
| NIH Device Record Key | 2a33267b-8bc6-4635-81f9-d86a9f44ca24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sodium Chloride Inhalation Solution, USP 0.9% 5mL |
| Version Model Number | 5mL |
| Company DUNS | 059295980 |
| Company Name | MYLAN PHARMACEUTICALS 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 | false |
| 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00303786986019 [Primary] |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-12-13 |
| 00303789300324 - Whisperject | 2018-07-06 The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with n |
| 00303786985012 - Sodium Chloride Inhalation Solution, USP, 0.9% 3mL UDV | 2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy |
| 00303786986019 - Sodium Chloride Inhalation Solution, USP 0.9% 5mL | 2018-03-29The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale. |
| 00303786986019 - Sodium Chloride Inhalation Solution, USP 0.9% 5mL | 2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy |
| 00303786987894 - Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL | 2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy |
| 00303786997893 - Sodium Chloride Inhalation Solution, USP, 3% 15mL | 2018-03-29 The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot |
| 00303786998890 - Sodium Chloride Inhalation Solution, USP 10% 15mL | 2018-03-29 The 10% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lo |