FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFEPAK CR Plus and LIFEPAK Express defibrillators
DI: 00883873820544
·
Model: 80403
·
PHYSIO-CONTROL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LIFEPAK CR Plus and LIFEPAK Express defibrillators
- Primary DI
- 00883873820544
- Version / Model
- 80403
- Catalog Number
- 80403-000119
- Company Name
- PHYSIO-CONTROL, INC.
- Labeler DUNS
- 009251992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-01
- Public Version
- 2
- Public Version Date
- 2020-05-20
- Public Version Status
- Update
- Public Device Record Key
- 61d73230-a0f6-4bfb-b6d9-30c27c55aabd
Device Description
PACKAGE,COMMERCIAL,LPCRPLUS,AUTO,CIRC PROMPT
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 |
|---|---|---|---|---|
| 48046 | Rechargeable public automated external defibrillator | A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it includes internal rechargeable batteries for energy that must be charged when not in use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00885074002033 | GS1 | ||||
| Primary | 00883873820544 | GS1 |
Customer Contacts
- Phone
- +1(800)442-1142
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage at extreme temperatures of -40C to 70C (-40F to 158F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius