Identity
- Trade Name
- Suction tip FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Model / Reference
- SU-xxxxx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622105807 FDA UDI
- 510(k) Number
- K982891 FDA UDI
- FDA Product Code
- DTS FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Surgical/emergency suction cannula, non-illuminating, single-use
Suction tip by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- Argyle — Cardinal Health 200, LLC · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- NETWORK — Network Medical Products, Ltd. · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
Cleared under the same submission
K982891 also covers:
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
- Suction tip — LivaNova USA, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI 2adc0f4b-ab7e-444f-b80a-51ce676913e6 33 fields · synced Jun 8, 2026