FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOLL Arrhythmia Management System
DI: 00855778005364
·
Model: Gateway
·
ZOLL MANUFACTURING CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZOLL Arrhythmia Management System
- Primary DI
- 00855778005364
- Version / Model
- Gateway
- Catalog Number
- 10A1088
- Company Name
- ZOLL MANUFACTURING CORPORATION
- Labeler DUNS
- 079320559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 3
- Public Version Date
- 2025-04-02
- Public Version Status
- Update
- Public Device Record Key
- 346b9b64-6eb4-4bb0-9dcd-624121993872
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65834 | Wearable multiple vital physiological parameter monitoring system | A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855778005364 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190939 | 000 |