FDA UDI
In Commercial Distribution
🇺🇸 United States
R SERIES
DI: 00847946030421
·
Model: 10001006001310013
·
Zoll Medical Corporation
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- R SERIES
- Primary DI
- 00847946030421
- Version / Model
- 10001006001310013
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-01
- Public Version
- 1
- Public Version Date
- 2020-12-09
- Public Version Status
- New
- Public Device Record Key
- b4a99b00-f121-4a83-9aae-6254d2665bf4
Device Description
Defibrillator, MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, NELLCOR, PACE, SPO2, NIBP, DMST, REFURB
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 |
|---|---|---|---|---|
| LDD | Dc-defibrillator, low-energy, (including paddles) | Cardiovascular | 870.5300 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
| DRO | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | Cardiovascular | 870.5550 | 2 |
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 | 00847946030421 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990762 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.8" x 10.3" x 8.2" |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity