Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Surgical irrigation/aspiration system pump FDA UDI
- Device Name
- Pulsewave Pump FDA UDI
- Model / Reference
- ASU1145 FDA UDI
- Description
- Pulsewave Pump FDA UDI
Identifiers
- Catalog Number
- ASU1145 FDA UDI
- Primary DI / UDI-DI
- 50885380003538 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Surgical irrigation/aspiration system pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration system pump
Cardinal Health by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CLEARVISION — Karl Storz GmbH & Co. KG · Class II
- CARDINAL HEALTH — Cardinal Health 200, 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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 76185257-42ca-47c5-9a73-aa37779f7668 34 fields · synced Jun 8, 2026