Identity
- Trade Name
- ZOLL Code Writer FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems. FDA UDI
- Model / Reference
- 9658-0304-01 FDA UDI
- Description
- Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946021894 FDA UDI
- 510(k) Number
- K132488 FDA UDI
- FDA Product Code
- NSX FDA UDIDXJ FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Regulation Number
- 870.2450 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
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
No
FDA UDI
Category: Medical equipment clinical data interfacing software
ZOLL Code Writer by Zoll Medical Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Care Orchestrator — Respironics, Inc. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (1)
- FDA UDI 4bbabdfb-2592-4c6d-8f07-c4bb2140a67b 34 fields · synced Jun 8, 2026