Duns Number:059295980
Device Description: The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used 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.
Catalog Number
400527460
Brand Name
Whisperject
Version/Model Number
400527460
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141384,K141384
Product Code
KZH
Product Code Name
Introducer, Syringe Needle
Public Device Record Key
8268ab9b-49ee-4468-a3c7-1da9a7a186fa
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
March 19, 2018
Package DI Number
10303789300321
Quantity per Package
18
Contains DI Package
00303789300324
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |