FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFEPAK 1000 defibrillator
DI: 00883873815465
·
Model: 99425
·
PHYSIO-CONTROL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LIFEPAK 1000 defibrillator
- Primary DI
- 00883873815465
- Version / Model
- 99425
- Catalog Number
- 99425-000025
- Company Name
- PHYSIO-CONTROL, INC.
- Labeler DUNS
- 009251992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-12
- Public Version
- 2
- Public Version Date
- 2020-05-18
- Public Version Status
- Update
- Public Device Record Key
- 64241240-5cd7-4347-8e92-2facc850f76d
Device Description
LP1000 CONFIGURED UNIT1000AAAABAAACBBAAAAAAAAA
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
- No
- 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 |
|---|---|---|---|---|
| 48049 | Non-rechargeable professional semi-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, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00885074698953 | GS1 | ||||
| Primary | 00883873815465 | GS1 |
Customer Contacts
- Phone
- +1(800)442-1142
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160026 | 007 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage at extreme temperatures of -30C to 60C (-22F to 140F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius