FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
DI: 00883873813850
·
Model: 70507
·
PHYSIO-CONTROL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors
- Primary DI
- 00883873813850
- Version / Model
- 70507
- Catalog Number
- 70507-000091
- Company Name
- PHYSIO-CONTROL, INC.
- Labeler DUNS
- 009251992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-16
- Public Version
- 2
- Public Version Date
- 2020-05-18
- Public Version Status
- Update
- Public Device Record Key
- 071772f3-0c03-4a20-a0ce-0b660be9ad26
Device Description
PKG LP20E CMM,PCNG,SPO2,AHA USAS,ENG
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|---|---|
| Previous | 00885074852133 | GS1 | ||||
| Primary | 00883873813850 | GS1 |
Customer Contacts
- Phone
- +1(800)442-1142
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage at extreme temperatures of -20 to 60 celsius (-4 or 140 Fahrenheit) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius