Identity
- Trade Name
- INTRAVENOUS INFUSION STARTER SET FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea IV Administration Set 1 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea IV Catheter Dressing 1 ea Transparent Film Dressing 1 ea 2"x2" Gauze Pad (2 pack) 1 ea FDA UDI
- Model / Reference
- 05 FDA UDI
- Description
- 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea IV Administration Set 1 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea IV Catheter Dressing 1 ea Transparent Film Dressing 1 ea 2"x2" Gauze Pad (2 pack) 1 ea FDA UDI
Identifiers
- Catalog Number
- 80-100 FDA UDI
- Primary DI / UDI-DI
- M68980100050 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Intravenous Infusion Starter Set by Safeguard Us Operating, Llc — 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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 0c9b7e93-0e24-45ca-ae21-9b331fae5a27 36 fields · synced May 30, 2026