7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tubing EUDAMED7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- 7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tubing EUDAMED
- Model / Reference
- 95701 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 95701 FDA UDI
- Primary DI / UDI-DI
- 00634624957015 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00634624957015 EUDAMED
- 510(k) Number
- K800825 FDA UDI
- FDA Product Code
- FPK FDA UDI
- EMDN Code
- A03020199 EXTENSIONS - OTHER EUDAMED
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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
7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub by Quest Medical Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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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 (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
- 8.5 in (22 cm) 3 Double T-site IV Extension Set — QUEST MEDICAL INC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quest Medical Inc
Sources (2)
- FDA UDI 72388006-76eb-4ce1-9717-ca4ffd480b0e 34 fields · synced Oct 7, 2026
- EUDAMED a6f2f9b0-77b8-4f17-8571-32504f2bd754 61 fields · synced Oct 7, 2026