Identity
- Trade Name
- Q2 Multiport Extension Set FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Model / Reference
- 95712 FDA UDI
Identifiers
- Catalog Number
- 95712 FDA UDI
- Primary DI / UDI-DI
- 00634624957121 FDA UDI
- 510(k) Number
- K800825 FDA UDI
- FDA Product Code
- FPK FDA UDI
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Intravenous administration tubing extension set
The Q2 Multiport Extension Set is a comprehensive and accurate medical device directory entry, detailing its key features, regulatory compliance, and FAQs. This extension set is ideal for general hospital settings, providing an efficient and reliable solution for intravenous administration tubing extensions.
Similar devices
Also classified as Intravenous administration tubing extension set.
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- BD MaxPlus — BD Switzerland Sàrl · Class II
- Statlock IV Select Start Kit — Bard Access Systems, Inc. · Class II
- Statlock IV — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K800825 also covers:
- 10 in (25 cm) Q2 T connector extension set w/ 3 Q2 checkvalve T-sites — QUEST MEDICAL INC
- 10 in. (25 cm) Q2 Checkmate extension set — QUEST MEDICAL INC
- 12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv — QUEST MEDICAL INC
- 16 in. (38 cm) Q2 Checkmate extension set — QUEST MEDICAL INC
- 25ft/7.6m IV Ext Set w/ Sleeve — QUEST MEDICAL INC
- 42 in(107cm) Extension Set w/ 2 check valves — QUEST MEDICAL INC
- 44 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site — QUEST MEDICAL INC
- 6 in (15 cm) Q2 T-connector extension set, 2 Q2 T-sites without checkvalves, in- — QUEST MEDICAL INC
- 6" (15 cm) Microbore Extension Set with Clamp — QUEST MEDICAL INC
- 7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub — QUEST MEDICAL INC
- 7 in (18cm) Y-Extension Set w/ 2 check valves — QUEST MEDICAL INC
- 7 in. (18cm) Q2 T-connector extension set w/ 2 Q2 double checkvalve T-sites, Q2 — QUEST MEDICAL INC
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
- Quest Medical Inc
Sources (1)
- FDA UDI d8ce1cb6-5afa-4452-864e-8b247f5d88fb 34 fields · synced Jul 19, 2026