Identity
- Trade Name
- QT Micro FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet. TM6100, case of 10, includes 5cc syringe of TSB Media. TM6101, case of 10, includes 5cc syringe of FTM Media FDA UDI
- Model / Reference
- Contamination Tester, luer slip outlet FDA UDI
- Description
- TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet. TM6100, case of 10, includes 5cc syringe of TSB Media. TM6101, case of 10, includes 5cc syringe of FTM Media FDA UDI
Identifiers
- Catalog Number
- TM6100 FDA UDI
- Primary DI / UDI-DI
- 00854989006108 FDA UDI
- 510(k) Number
- K950305 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose 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
No
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
Ethylene Oxide FDA UDI
Category: Fluid transfer set, general-purpose
QT Micro by Q.I. Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950305 also covers:
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
- Q.I. Medical, Inc.
Sources (1)
- FDA UDI bf970ee9-cddb-4c77-83dc-8148b51e8315 35 fields · synced Jun 1, 2026