Identity
- Trade Name
- POWERWAND FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable FDA UDI
- Model / Reference
- (ED) 3 Fr X 6 cm FDA UDI
- Description
- The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable FDA UDI
Identifiers
- Catalog Number
- 92019 FDA UDI
- Primary DI / UDI-DI
- 10859821006527 FDA UDI
- 510(k) Number
- K162322 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Peripheral vascular catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
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
Dimensions & Sizes
- Size
- Length — 6 Centimeter FDA UDICatheter Gauge — 3 French FDA UDI
Category: Peripheral vascular catheter
Powerwand by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular catheter.
- Arterial Line Kit — Argon Medical Devices, Inc. · Class I
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- POWERWAND — Access Scientific, Inc. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- DELTAVEN — DELTA MED SPA · Class II
Cleared under the same submission
K162322 also covers:
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI aad0eec5-4272-4765-8d42-d32c54ee44dd 38 fields · synced May 30, 2026