Identity
- Trade Name
- ERBEFLO CleverCap® FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- CO2 Olympus® Connector Tube FDA UDI
- Model / Reference
- 20325-219 FDA UDI
- Description
- CO2 Olympus® Connector Tube FDA UDI
Identifiers
- Catalog Number
- 20325-219 FDA UDI
- Primary DI / UDI-DI
- 04065655000917 FDA UDI
- 510(k) Number
- K132340 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic insufflation tubing set, single-use
ERBEFLO CleverCap® 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.
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- Clean Connecting Tube — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
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- 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
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
- Erbe Medical, LLC
Sources (1)
- FDA UDI 1b3e89ad-8a0c-47e0-bb17-336323b8201f 37 fields · synced May 30, 2026