Identity
- Trade Name
- SteriPath Gen2, Luer, BD FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- Steripath Blood Collection System, Sterile Pack, Luer, Long Neck TA FDA UDI
- Model / Reference
- 27BD-EN FDA UDI
- Description
- Steripath Blood Collection System, Sterile Pack, Luer, Long Neck TA FDA UDI
Identifiers
- Catalog Number
- 27BD-EN FDA UDI
- Primary DI / UDI-DI
- 00858366007054 FDA UDI
- 510(k) Number
- K192247 FDA UDI
- FDA Product Code
- JKA FDA UDIFPA FDA UDI
- GMDN Term
- Blood transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI880.5440 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood transfer setBlood collection set, noninvasive
SteriPath Gen2, Luer, BD by Magnolia Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood collection set, noninvasive.
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Cleared under the same submission
K192247 also covers:
- SteriPath Gen2, 21G — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 21G, 10ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 21G, 20ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 21G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 21G, TS — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 23G — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 23G, 10ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, 23G, TS — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, Luer — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, Luer, 10ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC.
- SteriPath Gen2, Luer, 20ml — MAGNOLIA MEDICAL TECHNOLOGIES, 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
- Magnolia Medical Technologies, Inc.
Sources (1)
- FDA UDI 7c76aca7-fbdc-480d-964c-f81b6b821ba7 35 fields · synced Jun 8, 2026