Identity
- Trade Name
- HAEMONETICS SMARTSUCTION HARMONY FDA UDI
- Generic Name
- General-purpose surgical suction system, electric FDA UDI
- Device Name
- SMARTSUCTION HARMONY FDA UDI
- Model / Reference
- HAR-E-115-US FDA UDI
- Description
- SMARTSUCTION HARMONY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30812747016968 FDA UDI
- 510(k) Number
- K052626 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- General-purpose surgical suction system, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Category: General-purpose surgical suction system, electric
Haemonetics Smartsuction Harmony by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose surgical suction system, electric.
- VC-701 — Stryker Corp. · Class II
- JEDMED — JEDMED Instrument Company · Class II
- Instavac I — Ohio Medical LLC · Class II
- Instavac C — Ohio Medical LLC · Class II
Cleared under the same submission
K052626 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
- Haemonetics Corporation
Sources (1)
- FDA UDI d475c689-43d6-4520-9864-c4273a985a1b 35 fields · synced Jun 8, 2026