Identity
- Trade Name
- Whisperject FDA UDI
- Generic Name
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 400527460 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 400527460 FDA UDI
- Primary DI / UDI-DI
- 00303789300324 FDA UDI
- 510(k) Number
- K141384 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Syringe-loaded medication/vaccine injector, manual, professional
Whisperject by Mylan Pharmaceuticals Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mylan Pharmaceuticals Inc.
Sources (1)
- FDA UDI 8268ab9b-49ee-4468-a3c7-1da9a7a186fa 36 fields · synced Jun 1, 2026