Identity
- Trade Name
- AutoPulse Li-ion Battery™ FDA UDI
- Generic Name
- Secondary battery FDA UDI
- Device Name
- Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform. FDA UDI
- Model / Reference
- 100 FDA UDI
- Description
- Box containing a Lithium Ion (Li-Ion) battery for use with the AutoPulse ® Platform. FDA UDI
Identifiers
- Catalog Number
- 8700-0752-29 FDA UDI
- Primary DI / UDI-DI
- 00849111001922 FDA UDI
- 510(k) Number
- K112998 FDA UDI
- FDA Product Code
- DRM FDA UDI
- GMDN Term
- Secondary battery 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: Secondary battery
AutoPulse Li-ion Battery™ by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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.
- 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 49244513-3bd3-4512-87d0-97c02d5957dd 37 fields · synced Jun 9, 2026