Identity
- Trade Name
- Exoflex 14.5in. IVExtension Set FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Model / Reference
- 95787 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634624957879 FDA UDI
- 510(k) Number
- K162304 FDA UDI
- FDA Product Code
- FPK FDA UDIFPA 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
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Intravenous administration tubing extension set
Exoflex 14.5in. IVExtension Set by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162304 also covers:
- 11.25 in Exoflex IV Ext Set — QUEST MEDICAL INC
- 16 in Exoflex IV Ext Set — QUEST MEDICAL INC
- 16 in. (38 cm) Q2 Checkmate extension set — QUEST MEDICAL INC
- 25ft/7.6m IV Extension Set — QUEST MEDICAL INC
- Exoflex 10.5in. IVExtension Set — QUEST MEDICAL INC
- Exoflex 10.5in. T-Extension Set — QUEST MEDICAL INC
- Exoflex 53in. T-Extension Set — QUEST MEDICAL INC
- Exoflex 53in. T-Extension Set — QUEST MEDICAL INC
- Exoflex 55in. T-Extension Set — QUEST MEDICAL INC
- Exoflex 9in. T-Extension Set — QUEST MEDICAL INC
- Exoflex 9in. T-Extension Set — QUEST MEDICAL INC
- High-Flow 4-Way Stopcock Extension — QUEST MEDICAL INC
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
- Quest Medical Inc
Sources (1)
- FDA UDI 30e98fc6-33d9-45c4-82a4-c192e1364ef6 33 fields · synced May 30, 2026