Identity
- Trade Name
- QUIK-STEP FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- ELECTRODES, 5-YEAR, LPCR2 FDA UDI
- Model / Reference
- 11103 FDA UDI
- Description
- ELECTRODES, 5-YEAR, LPCR2 FDA UDI
Identifiers
- Catalog Number
- 11103-000026 FDA UDI
- Primary DI / UDI-DI
- 00883873871577 FDA UDI
- PMA Number
- P170018 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillation electrode, adult, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillation electrode, adult, single-use
Quik-Step by PHYSIO-CONTROL, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, adult, single-use.
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- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
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- X SERIES MONITOR/DEFIBRILLATOR — Zoll Medical Corporation · Class III
- HeartStart Adult/Child Plus Pads — Philips Medical Systems Hsg · Class III
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- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
Cleared under the same submission
P170018 also covers:
- LIFEPAK — PHYSIO-CONTROL, Inc.
- LIFEPAK — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
- LIFEPAK CR2 — PHYSIO-CONTROL, Inc.
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
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI c6b65bda-d309-4c39-a7d2-7dd4a29d9678 37 fields · synced Jun 9, 2026