Identity
- Trade Name
- AngioJet® Ultra 5000A FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- Console FDA UDI
- Model / Reference
- 105650-001H FDA UDI
- Description
- Console FDA UDI
Identifiers
- Catalog Number
- 105650 FDA UDI
- Primary DI / UDI-DI
- 08714729890591 FDA UDI
- PMA Number
- P980037 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- General-purpose suction system, line-powered FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose suction system, line-powered
AngioJet® Ultra 5000A by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose suction system, line-powered.
- JETSTREAM — Bayer Healthcare · 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
- ANGIOJET — Bayer Healthcare · Class III
- Winx® — Apnicure, Inc. · Class II
- Winx® — Apnicure, Inc. · Class II
Cleared under the same submission
P980037 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI a5a1e8b2-cdae-4c13-b608-51edaeead5a5 35 fields · synced May 29, 2026