Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Peripheral intravenous catheterization support kit FDA UDI
- Device Name
- Syringe I.V. Access,Blunt Tip FDA UDI
- Model / Reference
- 8881541034 FDA UDI
- Description
- Syringe I.V. Access,Blunt Tip FDA UDI
Identifiers
- Catalog Number
- 8881541034 FDA UDI
- Primary DI / UDI-DI
- 10884521082953 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Peripheral intravenous catheterization support kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Category: Peripheral intravenous catheterization support kit
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral intravenous catheterization support kit.
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- IV Start Kit w/Catheter, 18Ga — Altitude Technologies Inc. · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Centurion — Centurion Medical Products · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
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
- Cardinalhealth
Sources (1)
- FDA UDI 4b1bf3bc-291e-478c-80ea-fc853c80e9fb 37 fields · synced May 30, 2026