Identity
- Trade Name
- JETSTREAM FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- JETSTREAM CONSOLE FDA UDI
- Model / Reference
- 050599-001 FDA UDI
- Description
- JETSTREAM CONSOLE FDA UDI
Identifiers
- Catalog Number
- 050599 FDA UDI
- Primary DI / UDI-DI
- 00616258005119 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- General-purpose suction system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Category: General-purpose suction system, line-powered
Jetstream by Bayer Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose suction system, line-powered.
- JETSTREAM™ PVCN100 — Boston Scientific · Class II
- Winx® — Apnicure, Inc. · Class II
- Meconium Aspirator — Neotech Products LLC · Class II
- Precision Medical — PRECISION MEDICAL, INC. · Class II
- Snorkel — Neotech Products LLC · Class II
- Winx® — Apnicure, Inc. · Class II
- Winx® — Apnicure, Inc. · Class II
- Winx® — Apnicure, Inc. · Class II
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
- Bayer Healthcare
Sources (1)
- FDA UDI 252f85fc-133e-4da7-8fa5-8a191634e9dd 36 fields · synced May 30, 2026