Identity
- Trade Name
- Hibercell PAN2111 FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Sample Collection Kit FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Sample Collection Kit FDA UDI
Identifiers
- Catalog Number
- 57 FDA UDI
- Primary DI / UDI-DI
- G292570 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hibercell PAN2111 by Biodesix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biodesix, Inc.
Sources (1)
- FDA UDI d4b0d2cb-c2f9-4ac0-81e6-a19d3d50a0f4 35 fields · synced May 30, 2026