Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Model / Reference
- SSU-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019778005140 FDA UDI
- 510(k) Number
- K841822 FDA UDI
- FDA Product Code
- DRM FDA UDI
- GMDN Term
- General-purpose suction system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5200 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
No
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
Category: General-purpose suction system, line-powered
Olympus by Keymed (Medical & Industrial Equipment), Ltd. — Class II — 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
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- 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
Cleared under the same submission
K841822 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 II | Pending data |
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Manufacturer
- Manufacturer
- Keymed (Medical & Industrial Equipment), Ltd.
Sources (1)
- FDA UDI 361d48e5-259f-4cc4-89ce-68b37c429542 33 fields · synced May 30, 2026