Identity
- Trade Name
- EXEL SAFETY PSV SET 21G X 3/4", 12" TUBE FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- EXEL SAFETY PSV SET 21G X 3/4", 12" TUBE, 50/BX, 500/CS FDA UDI
- Model / Reference
- 27804 FDA UDI
- Description
- EXEL SAFETY PSV SET 21G X 3/4", 12" TUBE, 50/BX, 500/CS FDA UDI
Identifiers
- Catalog Number
- 27804 FDA UDI
- Primary DI / UDI-DI
- 00020221278040 FDA UDI
- 510(k) Number
- K010197 FDA UDI
- FDA Product Code
- FPA FDA UDIFOZ FDA UDI
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI880.5200 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
Category: Blood collection set, invasive
Exel Safety Psv Set 21g X 3/4", 12" Tube by Exel International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood collection set, invasive.
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Cleared under the same submission
K010197 also covers:
- EXEL SAFETY PSV SET 23G X 3/4", 12" TUBE — Exel International
- EXEL SAFETY PSV SET 25G X 3/4", 12" TUBE — Exel International
- EXEL SAFETY PSV/M-S, L-A 21GX3/4", 12" TUBE — Exel International
- EXEL SAFETY PSV/M-S, L-A 23GX3/4"; 12" TUBE — Exel International
- EXEL SAFETY PSV/M-S, L-A 25GX3/4"; 12" TUBE — Exel International
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exel International
Sources (1)
- FDA UDI b600ed4c-a60f-4f2c-9ac1-6ff99f601e38 36 fields · synced May 29, 2026