Identity
- Trade Name
- SuperFlow Tubing Set FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Irrigation / Infiltration Tubing Set, Small FDA UDI
- Model / Reference
- 21512 FDA UDI
- Description
- Irrigation / Infiltration Tubing Set, Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850082007032 FDA UDI
- 510(k) Number
- K981286 FDA UDI
- FDA Product Code
- KDH FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Category: Surgical irrigation tubing set, single-use
SuperFlow Tubing Set by Armm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
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- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
Cleared under the same submission
K981286 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
- Armm Inc.
Sources (1)
- FDA UDI 5a81e971-172d-4fe9-a1ff-0f0bbb269387 35 fields · synced May 30, 2026