FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFEPAK CR2
DI: 00883873824115
·
Model: 99512
·
PHYSIO-CONTROL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIFEPAK CR2
- Primary DI
- 00883873824115
- Version / Model
- 99512
- Catalog Number
- 99512-001263
- Company Name
- PHYSIO-CONTROL, INC.
- Labeler DUNS
- 009251992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-08
- Public Version
- 2
- Public Version Date
- 2020-05-18
- Public Version Status
- Update
- Public Device Record Key
- c809880e-3022-497a-859b-4ffdf1c6dd72
Device Description
CR2BAAAABBHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48047 | Non-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 also includes a non-rechargeable battery for energy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00883873824115 | GS1 |
Customer Contacts
- Phone
- +1(800)442-1142
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170018 | 002 |
| P170018 | 003 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity