Identity
- Trade Name
- AutoPulse®Resuscitation System FDA UDI
- Generic Name
- Cardiac resuscitator, line-powered FDA UDI
- Device Name
- The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. FDA UDI
- Model / Reference
- 100 FDA UDI
- Description
- The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. FDA UDI
Identifiers
- Catalog Number
- 8700-0700-21 FDA UDI
- Primary DI / UDI-DI
- 00849111000093 FDA UDI
- 510(k) Number
- K112998 FDA UDI
- FDA Product Code
- DRM FDA UDI
- GMDN Term
- Cardiac resuscitator, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5200 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac resuscitator, line-powered
A comprehensive medical device directory resource, providing detailed information about the AutoPulse Resuscitation System. This device is designed to support cardiopulmonary resuscitation (CPR) efforts during cardiac arrest situations.
Similar devices
Also classified as Cardiac resuscitator, line-powered.
- Defibtech ACC Configuration — DEFIBTECH, L.L.C. · Class II
- Defibtech ACC Frame — DEFIBTECH, L.L.C. · Class II
- Defibtech ACC Compression Module — DEFIBTECH, L.L.C. · Class II
- ACC Rechargeble Battery Pack — DEFIBTECH, L.L.C. · Class II
- LUCAS — Jolife AB · Class II
- Defibtech ACC Frame Configuration — DEFIBTECH, L.L.C. · Class II
- Defibtech ACC Compression Module — DEFIBTECH, L.L.C. · Class II
- AutoPulse®Resuscitation System — ZOLL Circulation, Inc. · Class II
Cleared under the same submission
K112998 also covers:
- AutoPulse Battery — ZOLL Circulation, Inc.
- AutoPulse Battery — ZOLL Circulation, Inc.
- AutoPulse Battery — ZOLL Circulation, Inc.
- AutoPulse Li-ion Battery™ — ZOLL Circulation, Inc.
- AutoPulse Li-ion Battery™ — ZOLL Circulation, Inc.
- AutoPulse Li-ion Battery™ — ZOLL Circulation, Inc.
- AutoPulse Multi-Chemistry Battery Charger — ZOLL Circulation, Inc.
- AutoPulse® Resuscitation System — ZOLL Circulation, Inc.
- AutoPulse®Resuscitation System — ZOLL Circulation, Inc.
- AutoPulse®Resuscitation System — ZOLL Circulation, Inc.
- AutoPulse®Resuscitation System — ZOLL Circulation, Inc.
- AutoPulse®Resuscitation System — ZOLL Circulation, 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 II | Pending data |
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Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI 2cf0f90d-4270-4933-a201-69b5bdccab51 37 fields · synced Jul 20, 2026