Identity
- Trade Name
- Quick Connect FDA UDI
- Generic Name
- Luminal device flushing tubing set, reusable FDA UDI
- Device Name
- The Quick Connect for Pentax Ultrasound Videoscopes is used with the C3000XL Ultrasound Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. FDA UDI
- Model / Reference
- QPC3008E FDA UDI
- Description
- The Quick Connect for Pentax Ultrasound Videoscopes is used with the C3000XL Ultrasound Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. FDA UDI
Identifiers
- Catalog Number
- QPC3008E FDA UDI
- Primary DI / UDI-DI
- 00724995203344 FDA UDI
- 510(k) Number
- K090036 FDA UDIK101409 FDA UDIK102462 FDA UDIK113520 FDA UDIK131078 FDA UDIK161683 FDA UDIK170956 FDA UDIK173256 FDA UDIK180342 FDA UDIK182827 FDA UDIK190104 FDA UDIK191343 FDA UDIK192929 FDA UDIK210737 FDA UDIK211607 FDA UDIK222615 FDA UDIK232914 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Luminal device flushing tubing set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Luminal device flushing tubing set, reusable
Quick Connect by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090036 also covers:
K101409 also covers:
K102462 also covers:
K113520 also covers:
K131078 also covers:
K161683 also covers:
K170956 also covers:
K173256 also covers:
K180342 also covers:
K182827 also covers:
K190104 also covers:
K191343 also covers:
K192929 also covers:
K210737 also covers:
K211607 also covers:
K222615 also covers:
K232914 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Steris Corporation
Sources (1)
- FDA UDI 337d963a-12fa-4636-8223-2ff6517f3d0e 36 fields · synced Jun 8, 2026