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Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET
FDA UDIClass II (US FDA UDI)
by Biomedix-Inc
Identity
- Trade Name
- Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- B37 SELEC-3+NIS+LAS IV ADM. SET FDA UDI
- Model / Reference
- B37-102 FDA UDI
- Description
- B37 SELEC-3+NIS+LAS IV ADM. SET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851470007088 FDA UDI
- 510(k) Number
- K142097 FDA UDI
- FDA Product Code
- LHI 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
Yes
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
Yes
FDA UDI
Radiation Sterilization FDA UDI
MR Safe FDA UDI
Category: Intravenous administration tubing extension set
Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET by Biomedix-Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142097 also covers:
- Biomedix B10 SELEC-3 IV ADM. SET — BIOMEDIX-INC
- Biomedix B11 SELEC-3+SC IV ADM. SET — BIOMEDIX-INC
- Biomedix B12 SELEC-3+NIS IV ADM. SET — BIOMEDIX-INC
- Biomedix B15 SELEC-3+SC+NIS IV ADM. SET — BIOMEDIX-INC
- Biomedix B30 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B31 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B36 SELEC-3+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B38 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B39 SELEC-3+SC+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B62 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-INC
- Biomedix B72 SELEC-3+NIS+LAS IV ADM. SET — BIOMEDIX-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
- Biomedix-Inc
Sources (1)
- FDA UDI ebac06da-5f54-4383-b58a-d840c1488e35 34 fields · synced Jun 8, 2026