Whisperject 400527460
GUDID 00303789300324
The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
MYLAN PHARMACEUTICALS INC.
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| NIH Device Record Key | 8268ab9b-49ee-4468-a3c7-1da9a7a186fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Whisperject |
| Version Model Number | 400527460 |
| Catalog Number | 400527460 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00303789300324 [Primary] |
| GS1 | 10303789300321 [Package] Package: [18 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141384
FDA Product Code
| KZH | Introducer, Syringe Needle |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-19 |
Devices Manufactured by MYLAN PHARMACEUTICALS INC.
| 00303789300324 - Whisperject | 2018-07-06The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs. |
| 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 | 2018-03-29 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 |
Trademark Results [Whisperject]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WHISPERJECT 87553317 5396475 Live/Registered |
Mylan Pharmaceuticals, Inc. 2017-08-02 |
 WHISPERJECT 86180490 not registered Dead/Abandoned |
Mylan Pharmaceuticals, Inc. 2014-01-30 |
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