Identity
- Trade Name
- PureFlo FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- PureFlo Irrigation Tubing FDA UDI
- Model / Reference
- 1195-01 FDA UDI
- Description
- PureFlo Irrigation Tubing FDA UDI
Identifiers
- Catalog Number
- 1195-01 FDA UDI
- Primary DI / UDI-DI
- 00816734021439 FDA UDI
- FDA Product Code
- OCX FDA UDIFEQ FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
PureFlo by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
- SuperFlow Tubing Set — ARMM INC. · Class II
- Irrigation Set — B. BRAUN MEDICAL INC. · Class II
- EndoGator Hybrid — MEDIVATORS INC. · Class II
- IPC™ Visao® — MEDTRONIC XOMED, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
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
- Diversatek Healthcare
Sources (1)
- FDA UDI 96e1e884-c407-485d-89db-e7a603606fb1 35 fields · synced May 29, 2026