Identity
- Trade Name
- Diamondback Coronary FDA UDI
- Generic Name
- Atherectomy system saline/lubricant pump FDA UDI
- Device Name
- SALINE INFUSION PUMP (SIP) FDA UDI
- Model / Reference
- SIP-3000 FDA UDI
- Description
- SALINE INFUSION PUMP (SIP) FDA UDI
Identifiers
- Catalog Number
- 7-10037-07 FDA UDI
- Primary DI / UDI-DI
- 10852528005800 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- Atherectomy system saline/lubricant pump FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Atherectomy system saline/lubricant pump
Diamondback Coronary by Cardiovascular Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy system saline/lubricant pump.
- FLOWMATE® — Bard Peripheral Vascular · Class II
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cardiovascular Systems, Inc.
Sources (1)
- FDA UDI 05b62739-85ee-4774-bb13-3366ec1b94f6 35 fields · synced May 30, 2026