Identity
- Trade Name
- ERBEFLO AeroRinse® FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- CO2 and Water Tubing/Cap Set for Olympus® Scopes FDA UDI
- Model / Reference
- 20325-235 FDA UDI
- Description
- CO2 and Water Tubing/Cap Set for Olympus® Scopes FDA UDI
Identifiers
- Catalog Number
- 20325-235 FDA UDI
- Primary DI / UDI-DI
- 04065655000948 FDA UDI
- 510(k) Number
- K162152 FDA UDI
- FDA Product Code
- FEQ FDA UDI
- GMDN Term
- Endoscopic insufflation 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 0.4 Meter FDA UDI
Category: Endoscopic insufflation tubing set, single-use
ERBEFLO AeroRinse® by Erbe Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic insufflation tubing set, single-use.
- Suction Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Clean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Air/Water Bottle Tubing — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Steris — Canadian Hospital Specialties Limited · Class I
Cleared under the same submission
K162152 also covers:
- ERBEFLO AeroRinse® — Erbe Medical, LLC
- ERBEFLO AeroRinse® — Erbe Medical, LLC
- ERBEFLO AeroRinse® — Erbe Medical, LLC
- ERBEFLO CleverCap® — Erbe Medical, LLC
- ERBEFLO CleverCap® — Erbe Medical, LLC
- ERBEFLO CleverCap® — Erbe Medical, LLC
- ERBEFLO CleverCap® — Erbe Medical, LLC
- ERBEFLO CleverCap® — Erbe Medical, LLC
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
- Erbe Medical, LLC
Sources (1)
- FDA UDI fc317f68-f965-42bd-96e4-ae00e6efcbfe 38 fields · synced Jun 8, 2026