FDA UDI
In Commercial Distribution
🇺🇸 United States
X SERIES
DI: 00847946019211
·
Model: 620-2230411-01
·
Zoll Medical Corporation
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X SERIES
- Primary DI
- 00847946019211
- Version / Model
- 620-2230411-01
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-04
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e3cfd72c-194b-47ef-ab98-a1a1318b3f3e
Device Description
Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, TEMP, CPR EXPANSION PACK, DMST
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DSK | COMPUTER, BLOOD-PRESSURE | Cardiovascular | 870.1110 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DRO | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | Cardiovascular | 870.5550 | 2 |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Cardiovascular | 870.2300 | 2 |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17882 | Physiologic-monitoring defibrillation system | An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946019211 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112432 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8.9" x 10.4" x 8.75" |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal