Identity
- Trade Name
- AutoPulse®Resuscitation System FDA UDI
- Generic Name
- Cardiac resuscitator, battery-powered FDA UDI
- Device Name
- Head Immobilizer, 5-Pack (English) FDA UDI
- Model / Reference
- Head Immbolizer 5pk English FDA UDI
- Description
- Head Immobilizer, 5-Pack (English) FDA UDI
Identifiers
- Catalog Number
- 8700-0710 FDA UDI
- Primary DI / UDI-DI
- 10849111003053 FDA UDI
- 510(k) Number
- K112998 FDA UDI
- FDA Product Code
- DRM FDA UDI
- GMDN Term
- Cardiac resuscitator, battery-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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Cardiac resuscitator, battery-powered
AutoPulse®Resuscitation System by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac resuscitator, battery-powered.
- Defibtech ARM XR Compression Module Configuration — DEFIBTECH, L.L.C. · Class II
- Defibtech ARM XR Compression Module — DEFIBTECH, L.L.C. · Class II
- Defibtech ARM XR Suction Cup — DEFIBTECH, L.L.C. · Class II
- ROSC-U, Battery Control Unit — Resuscitation International · Class II
- ROSC-U System — Resuscitation International · Class II
- ROSC-U Wheeled/Storage Case — Resuscitation International · Class II
- ROSC-U, Disposables Pack (10) — Resuscitation International · Class II
- ROSC-U Battery Charger — Resuscitation International · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (1)
- FDA UDI 75663ed9-698e-4186-a821-825f4d513808 36 fields · synced Jun 9, 2026