Identity
- Trade Name
- Unifuser FDA UDI
- Generic Name
- Intravenous pressure infusor, manual, reusable FDA UDI
- Device Name
- UNIFUSOR+,REUSABLE,500ML,CUFF ONLY,WHTTUBE,EA FDA UDI
- Model / Reference
- Unifuser FDA UDI
- Description
- UNIFUSOR+,REUSABLE,500ML,CUFF ONLY,WHTTUBE,EA FDA UDI
Identifiers
- Catalog Number
- 1103XB FDA UDI
- Primary DI / UDI-DI
- 10841522127793 FDA UDI
- FDA Product Code
- KZD FDA UDI
- GMDN Term
- Intravenous pressure infusor, manual, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravenous pressure infusor, manual, reusable
Unifuser by Statcorp Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Statcorp Medical
Sources (1)
- FDA UDI bf9d5ee2-fd1c-4c6e-8bd1-6235500df47a 36 fields · synced May 30, 2026